Hebert - SQF System Elements for Manufacturing - SQF Code, Edition 8

Title Page

Site conducted
Hebert Candies LLC 2.5.5.1 SQF Internal Audit 10/29/2018 Rev 1
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System Elements

INSTRUCTIONS:
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SQF Code, edition 8

Opening Meeting
Name
Role

Facility Description

Facility Description
Number of Employees
Size
Production Schedule
General Layout
Other Pertinent Details

Auditor Recommendation

Recommendation

2.1 Management Commitment

2.1.1 Food Safety Policy (Mandatory)

2.1.1.1 Senior site management shall prepare and implement a policy statement that outlines as a minimum the: i. The site's commitment to supply safe food; ii. Methods used to comply with its customer and regulatory requirements and continually improve its food safety management system; and iii. The site's commitment to establish and review food safety objectives.
2.1.1.2 The policy statement shall be: i. Signed by senior site management; ii. Made available in language understood by all staff; and iii. Displayed in a prominent position; and iv. effectively communicated to all staff.

2.1.2 Management Responsibility (Mandatory)

2.1.2.1 The reporting structure describing those who have responsibility for food safety shall be identified and communicated within the site.
2.1.2.2 The senior site management shall make provision to ensure food safety practices and all applicable requirements of the SQF System are adopted and maintained.
2.1.2.3 The senior site management shall ensure adequate resources are available to achieve food safety objectives and support the development, implementation, maintenance and ongoing improvement of the SQF System.
2.1.2.4 Senior site management shall designate an SQF practitioner for each site with responsibility and authority to: i. Oversee the development, implementation, review and maintenance of the SQF System, including food safety fundamentals outlined in 2.4.2, and the food safety plan outlined in 2.4.3. 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.
2.1.2.5 The SQF practitioner shall: i. Be employed by the site as a company employee on a full-time basis; 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 and the requirements to implement and maintain SQF System relevant to the site's scope of certification.
2.1.2.6 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 have met the required competencies to carry out those functions affecting the legality and safety of food products.
2.1.2.7 Senior site management shall ensure that all staff are informed of their food safety and regulatory responsibilities, are aware of their role in meeting the requirements of the SQF food safety Code, and are informed of their responsibility to report food safety problems to personnel with authority to initiate action.
2.1.2.8 Job descriptions for those responsible for food safety shall be documented and include provisions to cover for the absence of key personnel.
2.1.2.9 Senior site management shall establish processes to improve the effectiveness of the SQF System to demonstrate continuous improvement
2.1.2.10 Senior site management shall ensure the integrity and continued operation of the food safety system in the event of organizational or personnel changes within the company or associated facilities.
2.1.2.11 Senior site management shall designate defined blackout periods that prevent unannounced re-certification audits from occurring out of season or when the site is not operating for legitimate business reasons. The list of blackout dates and their justification shall be submitted to the certification body a minimum of one (1) month before the sixty (60) day re-certification window for the agreed upon unannounced audit.

2.1.3 Management Review (Mandatory)

2.1.3.1 The senior site management shall be responsible for reviewing the SQF System and documenting the review procedure. Reviews shall include: i. The policy manual; ii. Internal and external audit findings; iii. Corrective actions and their investigations and resolution; iv. Customer complaints and their resolution and investigation; v. Hazard and risk management system; and vi. Follow-up action items from previous management review.
2.1.3.2 The SQF practitioner(s) shall update senior site management on a (minimum) monthly basis on matters impacting the implementation and maintenance of the SQF System. The updates and management responses shall be documented. The SQF System in its entirety shall be reviewed at least annually.
2.1.3.3 Food safety plans, Good Manufacturing Practices and other aspects of the SQF System shall be reviewed and updated as needed when any potential changes implemented have an impact on the site's ability to deliver safe food.
2.1.3.4 Records of all management reviews and updates shall be maintained.

2.1.4 Complaint Management (Mandatory)

2.1.4.1 The methods and responsibility for handling and investigating the cause and resolution of complaints from customers and authorities, arising from products manufactured or handled on site, shall be documented and implemented.
2.1.4.2 Trends of customer complaint data shall be investigated and analyzed by personnel knowledgeable about the incidents.
2.1.4.3 Corrective action shall be implemented based on the seriousness of the incident and as outlined in 2.5.5.
2.1.4.4 Records of customer complaints and their investigations shall be maintained.

2.1.5 Crisis Management Planning

2.1.5.1 A crisis management plan that is based on the understanding of known potential dangers (e.g. flood, drought, fire, tsunami, or other severe weather or regional events such as warfare or civil unrest) 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.
2.1.5.2 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 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.
2.1.5.3 The crisis management plan shall be reviewed, tested and verified at least annually.
2.1.5.4 Records of reviews of the crisis management plan shall be maintained.

2.2 Document Control and Records

2.2.1 Food Safety Management System (Mandatory)

2.2.1.1 A food safety management system shall be documented and maintained in either electronic and/or hard copy form. It shall outline the methods the organization will use to meet the requirements of the SQF Food Safety Code, 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 scope of the certification; iv. A list of the products covered under the scope of certification; v. Food safety procedures, pre-requisite programs, HACCP-based food safety plans; and vi. Other documentation necessary to support the development and the implementation, maintenance and control of the SQF System.
2.2.1.2 All changes made to food safety plans, Good Manufacturing Practices and other aspects of the SQF System shall be validated or justified.

2.2.2 Document Control (Mandatory)

2.2.2.1 The methods and responsibility for maintaining document control and ensuring staff have access to current documents shall be documented and implemented.
2.2.2.2 A register of current SQF System documents and amendments to documents shall be maintained.
2.2.2.3 Documents shall be safely stored and readily accessible.

2.2.3 Records (Mandatory)

2.2.3.1 The methods and responsibility for undertaking monitoring activities, verifying, maintaining and retaining records shall be documented and implemented.
2.2.3.2 All records shall be legible and suitably authorized 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 damage and deterioration and shall be retained in accordance with periods specified a customer or regulations.

2.3 Specification and Product Development

2.3.1 Product Development and Realization

2.3.1.1 The methods and responsibility for designing, developing and converting product concepts to commercial realization shall be documented and implemented.
2.3.1.2 Product formulation, manufacturing processes and the fulfillment of product requirements shall be validated by site trials, shelf life trials and product testing.
2.3.1.3 Shelf life trials where necessary shall be conducted to establish and validate a product’s: i. Handling, and storage requirements including the establishment of “use by” or “best before dates""; ii. Microbiological criteria; and iii. Consumer preparation, storage and handling requirements.
2.3.1.4 A food safety plan shall be validated and verified for each new product and its associated process through conversion to commercial production and distribution, or where a change to ingredients, process, or packaging occurs that may impact food safety.
2.3.1.5 Records of all product design, process development, shelf life trials and approvals shall be maintained.

2.3.2 Raw and Packaging Materials

2.3.2.1 Specifications for all raw and packaging materials, including, but not limited to ingredients, additives, hazardous chemicals and processing aids that impact on finished product safety shall be documented and kept current.
2.3.2.2 All raw and packaging materials and ingredients shall comply with the relevant legislation in the country of manufacture and country of destination, if known.
2.3.2.3 The methods and responsibility for developing and approving detailed raw material, ingredient, and packaging specifications shall be documented.
2.3.2.4 Raw and packaging materials and ingredients shall be validated to ensure product safety is not compromised and the material is fit for its intended purpose. Verification of raw materials and ingredients shall include certificates of conformance, or certificate of analysis, or sampling and testing.
2.3.2.5 Verification of packaging materials shall include: i. Certification that all packaging that comes into direct contact with food meets either regulatory acceptance or approval criteria. Documentation shall either be in the form of a declaration of continued guarantee of compliance, a certificate of conformance, or a certificate from the applicable regulatory agency. ii. In the absence of a certificate of conformance, certificate of analysis, or letter of guarantee, tests and analyses to confirm the absence of potential chemical migration from the packaging to the food contents shall be conducted and records maintained.
2.3.2.6 Finished product labels shall be accurate, comply with the relevant legislation and be approved by qualified company personnel.
2.3.2.7 A register of raw and packaging material specifications and labels shall be maintained and kept current.

2.3.3 Contract Service Providers

2.3.3.1 Specifications for contract services that have an impact on product safety shall be documented, current, include a full description of the service to be provided and detail relevant training requirements of all contract personnel.
2.3.3.2 A register of all contract service specifications shall be maintained.

2.3.4 Contract Manufacturers

2.3.4.1 The methods and responsibility for ensuring all agreements relating to food safety and customer product requirements and its realization and delivery are specified and agreed shall be documented and implemented.
2.3.4.2 The site shall: i. Verify compliance with the SQF Food Safety Code and that all customer requirements are being met at all times. Products and/or processes of co-manufacturers that are considered high risk shall be required to undergo an audit by the site or other third party agency to confirm compliance to the SQF food safty Code and agreed arrangements; and ii. Ensure changes to contractual agreements are approved by both parties and communicated to relevant personnel.
2.3.4.3 Records of all contract reviews and changes to contractual agreements and their approvals shall be maintained.

2.3.5 Finished Product Specifications

2.3.5.1 Finished product specifications shall be documented, current, approved by the site and their customer, accessible to relevant staff and may include: i. Microbiological and chemical limits; and ii. Labeling and packaging requirements.
2.3.5.2 A register of finished product specifications shall be maintained.

2.4 Food Safety System

2.4.1 Food Legislation (Mandatory)

2.4.1.1 The site shall ensure that, at the time of delivery to its customer, the food supplied shall comply with the legislation that applies to the food and its production in the country of use or sale. This includes compliance with legislative requirements applicable to maximum residue limits, food safety, packaging, product description, net weights, nutritional, allergen and additive labeling, labeling of identify preserved foods, any other criteria listed under food legislation, and to relevant established industry codes of practice.
2.4.1.2 The methods and responsibility for ensuring the site is kept informed of changes to relevant legislation, scientific and technical developments, emerging food safety issues, and relevant industry codes of practice shall be documented and implemented.
2.4.1.3 SQFI and the certification body shall be notified in writing within twenty-four (24) hours in the event of a regulatory warning. Notification to SQFI shall be by email to foodsafetycrisis@sqfi.com.

2.4.2 Good Manufacturing Practices (Mandatory)

2.4.2.1 The site shall ensure the Good Manufacturing Practices described in modules 3, 4, 9, 10 or 11 (as applicable) 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.
2.4.2.2 Those Good Manufacturing Practices applicable to the scope of certification that outline the means by which food safety is controlled and assured shall be documented and implemented.

2.4.3 Food Safety Plan (Mandatory)

2.4.3.1 A food safety plan shall be prepared in accordance with the twelve steps identified in the Codex Alimentarius Commission HACCP guidelines. Feed Manufacturers may utilize a HACCP-based reference food safety plan developed by a responsible authority.
2.4.3.2 The food safety plan shall be effectively implemented, and 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.
2.4.3.3 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.
2.4.3.4 The scope of each food safety plan shall be developed and documented including the start and end-point 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 safety plans. This shall reference the finished product specifications (2.3.5.1) plus any additional information relevant to product safety, such as pH, water activity, and/or composition.
2.4.3.6 The intended use of each product shall be determined and documented by the food safety team. This shall include target consumer groups, the potential for consumption by vulnerable groups of the population, requirements for further processing if applicable, and potential alternative use of the product.
2.4.3.7 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, and service inputs (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 during all stages and hours of operation.
2.4.3.8 The food safety team shall identify and document all food safety hazards that can reasonably be expected to occur at each step in the processes, including raw materials and other inputs.
2.4.3.9 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.
2.4.3.10 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.
2.4.3.11 Based on the results of the hazard analysis (2.4.3.9), 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.
2.4.3.12 For each identified CCP, the food safety team shall identify and document the limits that separate safe from unsafe product. 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 2.5.2.1).
2.4.3.13 The food safety team shall develop and document procedures to monitor CCPs to ensure they remain within the established limits (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 safety team shall develop and document deviation procedures that identify the disposition of affected product when monitoring indicates a loss of control at a CCP. The procedures shall also prescribe actions to correct the process step to prevent recurrence of the safety failure.
2.4.3.15 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.
2.4.3.16 Implemented food safety plans shall be verified as part of SQF System verification (refer to 2.5).
2.4.3.17 Where food safety regulations in the country of production and destination (if known) prescribe a food safety control methodology other than the Codex Alimentarius Commission HACCP guidelines, the food safety team shall implement food safety plans that meet both Codex and food regulatory requirements.

2.4.4 Approved Supplier Program (Mandatory)

2.4.4.1 Raw materials, ingredients, packaging materials, and services that impact on finished product safety shall meet the agreed specification (refer to 2.3.2) and be supplied by an approved supplier.
2.4.4.2 The receipt of raw materials, ingredients, and packaging materials received from non-approved suppliers shall be acceptable only in an emergency situation, and provided they are inspected or analyzed before use.
2.4.4.3 The responsibility and procedure for selecting, evaluating, approving and monitoring an approved supplier shall be documented and implemented.
2.4.4.4 The site's food defense plan (refer to 2.7.1.1) shall include measures to secure incoming materials and ingredients and protect them from deliberate act of sabotage or terrorist-like incidents.
2.4.4.5 The site's food fraud vulnerability assessment (refer to 2.7.2.1) shall include the site's susceptibility to raw material or ingredient substitution, mislabeling, or dilution and counterfeiting which may adversely impact food safety.
2.4.4.6 The food fraud mitigation plan (refer to 2.7.2.2) shall include methods by which the identified food safety vulnerabilities from ingredients and materials shall be controlled.
2.4.4.7 Raw materials, ingredients, and packaging materials received from other facilities under the same corporate ownership, shall be subject to the same specification requirements (refer to 2.3.2) and approved supplier requirements as all other material providers.
2.4.4.8 The approved supplier program shall be based on the prior performance of a supplier and the risk level of the raw materials ingredients, packaging materials, and services supplied, and shall contain as a minimum: i. Agreed specifications (refer to 2.3.2); ii. Reference to the rating of the level of risk applied to a raw material ingredients, packaging materials and services and the approved supplier; iii. A summary of the food safety controls implemented by the approved supplier; iv. Methods for granting approved supplier status; v. Methods and frequency of monitoring approved suppliers; vi. Details of the certificates of conformance if required; and vii. Methods and frequency of reviewing approved supplier performance and status.
2.4.4.9 Supplier audits shall be based on risk and shall be conducted by individuals knowledgeable of applicable regulatory and food safety requirements risk and trained in auditing techniques.
2.4.4.10 A register of approved supplier and records of inspections and audits of approved suppliers shall be maintained.

2.4.5 Non-conforming Product or Equipment

2.4.5.1 The responsibility and methods outlining how non-conforming product, raw material, ingredient, work-in-progress, packaging or equipment detected during receipt, storage, processing, handling 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. Non-conforming equipment is effectively repaired or disposed of in a manner that minimizes the risk of inadvertent use, improper use or risk to the integrity of finished product; and iii. All relevant staff are aware of the organization’s quarantine and release requirements applicable to equipment or product placed under quarantine status.
2.4.5.2 Quarantine records, and records of the handling, corrective action, or disposal of non-conforming product or equipment shall be maintained.

2.4.6 Product Rework

2.4.6.1 The responsibility and methods outlining how ingredients, packaging materials, or products are reworked shall be documented and implemented. The methods applied shall ensure: i. Reworking operations are supervised by qualified personnel; ii. Reworked product is clearly identified and traceable; iii. Each batch of reworked product is inspected or analyzed as required before release; iv. Inspections and analyses shall conform to the requirements outlined in element 2.5.6; and v. Release of reworked product shall conform to element 2.4.7.
2.4.6.2 Records of all reworking operations shall be maintained.

2.4.7 Product Release (Mandatory)

2.4.7.1 The responsibility and methods for releasing products shall be documented and implemented. The methods applied shall ensure the product is released: i. By authorized personnel; and ii. Once all inspections and analyses are successfully completed and documented to verify legislative and other established food safety controls have been met.
2.4.7.2 Records of all product release shall be maintained.

2.4.8 Environmental Monitoring

2.4.8.1 A risk-based environmental monitoring program shall be in place for all food and pet food manufacturing processes.
2.4.8.2 The responsibility and methods for the environmental monitoring program shall be documented and implemented.
2.4.8.3 An environmental sampling and testing schedule shall be prepared, detailing the applicable pathogens or indicator organisms to test for that industry, the number of samples to be taken and the frequency of sampling.
2.4.8.4 Environmental testing results shall be monitored and corrective actions (refer 2.5.3.1) implemented where unsatisfactory trends are observed.

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 ensure that: i. Good Manufacturing Practices are confirmed to ensure they achieve the required result; ii. Critical food safety limits are validated, and re-validated annually; iii. Changes to the processes or procedures are assessed to ensure controls are still effective; and iv. All applicable elements of the SQF program are implemented and effective.
2.5.1.2 Records of all validation activities shall be maintained.

2.5.2 Verification Activities (Mandatory)

2.5.2.1 A verification schedule outlining the verification activities, their frequency of completion and the person responsible for each activity shall be prepared and implemented.
2.5.2.2 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.
2.5.2.3 Records of the verification of monitoring activities shall be maintained.

2.5.3 Corrective and Preventative Action (Mandatory)

2.5.3.1 The responsibility and methods outlining how corrections and corrective 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.
2.5.3.2 Records of all investigation and resolution of non-conformities including their corrections and corrective action shall be maintained.

2.5.4 Product Sampling, Inspection and Analysis

2.5.4.1 The methods, responsibility and criteria for sampling, inspecting and/or analyzing raw materials, finished product and work in progress shall be documented and implemented. The methods applied shall ensure: i. Inspections and analyses are completed at regular intervals as required and to agreed specification and legal requirements; ii. Inspections are conducted to ensure raw materials, work in process and finished products comply with the relevant specification, regulatory requirements and are true to label; and iii. All analyses are conducted to nationally recognized methods or alternative methods which are validated as equivalent to the nationally recognized methods.
2.5.4.2 On-site personnel that conduct environmental or product testing shall participate in an applicable proficiency testing program at least annually to ensure accuracy of results.
2.5.4.3 Where external laboratories are utilized to conduct input or product analysis, the laboratories shall be accredited to ISO 17025 or an equivalent national standard, and shall be included on the site's contract service specifications register (refer to 2.3.3.1).
2.5.4.4 Records of all inspections and analyses shall be maintained.

2.5.5 Internal Audits and Inspections (Mandatory)

2.5.5.1 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 at least annually. The methods applied shall ensure: i. All applicable requirements of the SQF Food Safety Code are audited as per the SQF audit checklist or similar tool; ii. Correction and corrective 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.
2.5.5.2 Staff conducting internal audits shall be trained and competent in internal audit procedures.
2.5.5.3 Regular inspections of the site and equipment shall be planned and carried out to verify Good Manufacturing Practices and building/equipment maintenance is compliant to the SQF Food Safety Code. The site shall: i. Take corrections or corrective and preventative action; and ii. Maintain records of inspections and any corrective action taken.
2.5.5.4 Where practical staff conducting internal audits shall be independent of the function being audited.
2.5.5.5 Records of internal audits and inspections and any corrections and corrective action taken as a result of internal audits shall be maintained.

2.6 Product Identification, Trace, Withdrawal and Recall

2.6.1 Product Identification (Mandatory)

2.6.1.1 The methods and responsibility for identifying raw materials, ingredients, packaging materials, work-in progress, process inputs and finished products during all stages of production and storage shall be documented and implemented. The product identification system shall be implemented to ensure: i. Raw materials, ingredients, packaging materials, work-in 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.
2.6.1.2 Product identification records shall be maintained.
2.6.1.3 Product start up and changeover procedures during packing 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.

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 to the customer (one up) and provides traceability through the process to the manufacturing supplier and date of receipt of raw materials, food contact packaging and materials and other inputs (one back); ii. Traceability is maintained where product is reworked; and iii. The effectiveness of the product trace system shall be reviewed at least annually as part of the product recall and withdrawal review (refer to 2.6.3.3).

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 and expert advice; and 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. iv. SQFI, the certification body, and the appropriate regulatory authority shall be listed as an essential body and notified in instances of a food safety incident of a public nature, or product recall for any reason.
2.6.3.2 Investigation shall be undertaken to determine the root cause of a withdrawal, mock recall or recall and details of investigations and any action taken shall be documented.
2.6.3.3 The product withdrawal and recall system shall be reviewed, tested and verified as effective at least annually. Testing shall include incoming materials (one step back) and finished product (one up).
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.

2.7 Food Defense and Food Fraud

2.7.1 Food Defense Plan (Mandatory)

2.7.1.1 The methods, responsibility and criteria for preventing food adulteration caused by a deliberate act of sabotage or terrorist-like incident shall be documented, implemented and maintained.
2.7.1.2 A food defense plan shall include: i. The name of the senior site management person responsible for food defense; ii. The methods implemented to ensure only authorized personnel have access to production equipment and vehicles, manufacturing and storage areas through designated access points; iii. The methods implemented to protect sensitive processing points from intentional adulteration; iv. The measures taken to ensure the secure receipt and storage of raw materials, packaging, equipment and hazardous chemicals; v. The measures implemented to ensure raw materials, ingredients, packaging materials, work-in progress, process inputs and finished products are held under secure storage and transportation conditions; and vi. The methods implemented to record and control access to the premises by employees, contractors, and visitors.
2.7.1.3 The food defense plan shall be reviewed and challenged at least annually.

2.7.2 Food Fraud

2.7.2.1 The methods, responsibility and criteria for identifying the site's vulnerability to food fraud shall be documented, implemented and maintained. The food fraud vulnerability assessment shall include the site's susceptibility to product substitution, mislabeling, dilution and counterfeiting which may adversely impact food safety.
2.7.2.2 A food fraud mitigation plan shall be developed and implemented which specifies the methods by which the identified food fraud vulnerabilities shall be controlled.
2.7.2.3 The food fraud vulnerability assessment and mitigation plan shall be reviewed and verified at least annually.

2.8 Allergen Management

2.8.1 Allergen Management for Food Manufacturing (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 from locker rooms, vending machines, lunch rooms, visitors; iii. A register of allergens which is applicable in the country of manufacture and the country(ies) of destination if known; iv. A list of allergens which is accessible by relevant staff. v. The hazards associated with allergens and their control incorporated into the food safety plan. vi. A management plan for control of identified allergens. The allergen management program shall include the identification, management, and labelling of products containing gluten, where applicable.
2.8.1.3 Provision shall be made to clearly identify and segregate foods that contain allergens. Segregation procedures shall be implemented and continually monitored.
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. Separate handling and production equipment shall be provided where satisfactory line hygiene and clean-up or segregation is not possible.
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 effectively implemented.
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.
2.8.1.7 The product identification system shall make provision for clear identification and labeling in accordance with regulatory requirements of those products produced on production lines and equipment on which foods containing allergens were manufactured.
2.8.1.8 The site shall document and implement methods to control the accuracy of finished product labels (or consumer information where applicable) and assure work in progress and finished product is true to label with regard to allergens. Such measures may include label approvals at receipt, label reconciliations during production, destruction of obsolete labels, and verification of labels on finished product as appropriate and product change over procedures.
2.8.1.9 The product trace system shall take into consideration the conditions under which allergen containing foods are manufactured and ensure full trace back of all ingredients and processing aids used.
2.8.1.10 Re-working of product containing food allergen shall be conducted under conditions that ensure product safety and integrity is maintained. Re-worked product containing allergens shall be clearly identified and traceable.
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 introducing unintended allergens through supplier, contract manufacturer, employee and visitor activities.

2.8.2 Allergen Management for Pet Food Manufacturing (Mandatory)

2.8.2.1 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 inputs and processing aids, including food grade lubricants, that contain food allergens; ii. An assessment of workplace-related food allergens from locker rooms, vending machines, lunch rooms, and/or visitors; iii. A list of allergens which is accessible by relevant staff. ; and iv. The hazards associated with allergens and their control incorporated into the food safety plan.
2.8.2.2 Product labeling, in accordance with regulatory requirements, shall include allergens where risks from cross-contact have been identified.

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.

2.9.2 Training Program (Mandatory)

2.9.2.1 An employee training program shall be documented and implemented. It shall outline the necessary competencies for specific duties and the training methods to be applied for those staff carrying out tasks associated with: i. Developing and applying Good Manufacturing Practices; ii. Applying food regulatory requirements; iii. Steps identified by the hazard analysis and/or other instructions as critical to effective implementation of the food safety plan and the maintenance of food safety; and iv. Tasks identified as critical to meeting the effective implementation and maintenance of the SQF System.

2.9.3 Instructions

2.9.3.1 Instructions shall be available in the languages relevant to the staff, explaining how all tasks critical to meeting regulatory compliance, the maintenance of food safety and how process efficiency are to be performed.

2.9.4 HACCP Training Requirements

2.9.4 Compliance?

2.9.5 Language

2.9.5 Compliance?

2.9.6 Refresher Training

2.9.6.1 The training program shall include provision for identifying and implementing the refresher training needs of the organization.

2.9.7 Training Skills Register

2.9.7.1 A training skills register describing who has been trained in relevant skills shall be maintained. The register shall indicate the: i. Participant name; ii. Skills description; iii. Description of the training provided; iv. Date training completed; v. Trainer or training provider; and vi. Supervisor’s verification the training was completed and that the trainee is competent to complete the required tasks.

Module 11: Good Manufacturing Practices for Processing of Food Products (GFSI El, Ell, Elll, ElV and L)

11.1 Site Location and Construction

11.1.1 Premises Location and Approval

11.1.1.1 The location of the premises shall be such that adjacent and adjoining buildings, operations and land use do not interfere with safe and hygienic operations.
11.1.1.2 The construction and ongoing operation of the premises on the site shall be approved by the relevant authority.

11.2 Construction of Premises and Equipment

11.2.1 Materials and Surfaces

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

11.2.2 Floors, Drains, and Waste Traps

11.2.2.1 Floors shall be constructed of smooth, dense impact resistant material that can be effectively graded, drained, impervious to liquid and easily cleaned.
11.2.2.2 Floors shall be sloped to floor drains at gradients suitable to allow the effective removal of all overflow or waste water under normal working conditions.
11.2.2.3 Drains shall be constructed and located so they can be easily cleaned and not present a hazard.
11.2.2.4 Waste trap system shall be located away from any food handling area or entrance to the premises.

11.2.3 Walls, Partitions, Floors and Ceilings

11.2.3.1 Walls, partitions, ceilings and doors shall be of durable construction. Internal surfaces shall be smooth and impervious with a light colored finish, and shall be kept clean (refer to element 11.2.13.1).
11.2.3.2 Wall-to-wall and wall-to-floor junctions shall be designed to be easily cleaned and sealed to prevent the accumulation of food debris.
11.2.3.3 Ducting, conduit and pipes that convey services such as steam or water shall be designed and constructed so as to prevent the contamination of food, ingredients and food contact surfaces and allow ease of cleaning.
11.2.3.4 Pipes carrying sanitary waste or waste water that are located directly over product lines or storage areas shall be designed and constructed so as to prevent the contamination of food, materials, ingredients and food contact surfaces, and shall allow ease of cleaning.
11.2.3.5 Doors, hatches and windows and their frames in food processing, handing or storage areas shall be of a material and construction which meets the same functional requirements as for internal walls and partitions. Doors and hatches shall be of solid construction and windows shall be made of shatterproof glass or similar material.
11.2.3.6 Product shall be processed and handled in areas that are fitted with a ceiling or other acceptable structure that is constructed and maintained to prevent the contamination of products.
11.2.3.7 Drop ceilings shall be constructed to enable monitoring for pest activity, facilitate cleaning and provide access to utilities.

11.2.4 Stairs, Catwalks and Platforms

11.2.4.1 Stairs, catwalks and platforms in food processing and handling areas shall be designed and constructed so as not to present a product contamination risk, and with no open grates directly above exposed food product surfaces. They shall be kept clean (refer to element 11.2.13.1).

11.2.5 Lightings and Light Fittings

11.2.5.1 Lighting in food processing and handling areas and at inspection stations shall be of appropriate intensity to enable the staff to carry out their tasks efficiently and effectively.
11.2.5.2 Light fittings in processing areas, inspection stations, ingredient and packaging storage areas, and all areas where the product is exposed shall be shatterproof, manufactured with a shatterproof covering or fitted with protective covers and recessed into or fitted flush with the ceiling. Where fittings cannot be recessed, structures must be protected from accidental breakage, manufactured from cleanable materials and addressed in the cleaning and sanitation program.
11.2.5.3 Light fittings in warehouses and other areas where the product is protected shall be designed such as to prevent breakage and product contamination.

11.2.6 Inspection / Quality Control Area

11.2.6.1 A suitable area shall be provided for the inspection of the product if required.
11.2.6.2 The inspection/quality control area shall be provided with facilities that are suitable for examination and testing of the type of product being handled/processed. The inspection area shall:

11.2.7 Dust, Insect, and Pest Proofing

11.2.7.1 All external windows, ventilation openings, doors and other openings shall be effectively sealed when closed and proofed against dust, vermin and other pests.
11.2.7.2 External personnel access doors shall be provided. They shall be effectively insect-proofed and fitted with a self-closing device and proper seals to protect against ingress of dust, vermin and other pests.
11.2.7.3 External doors, including overhead dock doors in food handling areas used for product, pedestrian or truck access shall be insect-proofed by at least one or a combination of the following methods: i. A self-closing device; ii. An effective air curtain; iii. An insect-proof screen; iv. An insect-proof annex; v. Adequate sealing around trucks in docking areas.
11.2.7.4 Electric insect control devices, pheromone or other traps and baits shall be located so as not to present a contamination risk to the product, packaging, containers or processing equipment. Poison rodenticide bait shall not be used inside ingredient or product storage areas or processing areas.

11.2.8 Ventilation

11.2.8.1 Adequate ventilation shall be provided in enclosed processing and food handling areas.
11.2.8.2 All ventilation equipment and devices in product storage and handling areas shall be adequately cleaned as per 11.2.12, to prevent unsanitary conditions.
11.2.8.3 Extractor fans and canopies shall be provided in areas where cooking operations are carried out or a large amount of steam is generated and shall have the following features: i. Capture velocities shall be sufficient to prevent condensation build up and to evacuate all heat, fumes and other aerosols to the exterior via an exhaust hood positioned over cooker; ii. Fans and exhaust vents shall be insect-proofed and located so as not to pose a contamination risk; and iii. Where appropriate, positive air-pressure system shall be installed to prevent airborne contamination.

11.2.9 Equipment, Utensils, and Protective Clothing

11.2.9.1 Specifications for equipment, utensils and protective clothing, and procedures for purchasing equipment shall be documented and implemented.
11.2.9.2 Equipment and utensils shall be designed, constructed, installed, operated and maintained so as to meet any applicable regulatory requirements and not to pose a contamination threat to products.
11.2.9.3 Benches, tables, conveyors, mixers, mincers, graders and other mechanical processing equipment shall be hygienically designed and located for appropriate cleaning. Equipment surfaces shall be smooth, impervious and free from cracks or crevices.
11.2.9.4 Product containers, tubs, bins for edible and inedible material shall be constructed of materials that are non-toxic, smooth, impervious and readily cleaned as per 11.2.13. Bins used for inedible material shall be clearly identified.
11.2.9.5 Waste and overflow water from tubs, tanks and other equipment shall be discharged direct to the floor drainage system, and to meet local regulatory requirements.
11.2.9.6 Protective clothing shall be manufactured from material that will not contaminate food and is easily cleaned.
11.2.9.7 Racks shall be provided for the temporary storage of protective clothing when staff leaves the processing area and shall be provided in close proximity or adjacent to the personnel access doorways and hand washing facilities.
11.2.9.8 All equipment, utensils and protective clothing shall be cleaned after use or at a frequency to control contamination, and stored in a clean and serviceable condition to prevent microbiological or cross-contact allergen contamination.

11.2.10 Premises and Equipment Maintenance

11.2.10.1 The methods and responsibility for the maintenance and repair of plant, equipment and buildings shall be documented, planned and implemented in a manner that minimizes the risk of product, packaging or equipment contamination.
11.2.10.2 Routine maintenance of plant and equipment in any food processing, handling or storage area shall be performed according to a maintenance-control schedule and recorded. The maintenance schedule shall be prepared to cover building, equipment and other areas of the premises critical to the maintenance of product safety and quality.
11.2.10.3 Failures of plant and equipment in any food processing, handling or storage area shall be documented, reviewed and their repair incorporated into the maintenance control schedule.
11.2.10.4 Maintenance staff and contractors shall comply with the facility’s personnel and process hygiene requirements (refer to elements 11.3.1, 11.3.2, 11.3.3, 11.3.4).
11.2.10.5 All maintenance and other engineering contractors required to work on site shall be trained in the site's food safety and hygiene procedures, or shall be escorted at all times, until their work is completed.
11.2.10.6 Site supervisors shall be notified when maintenance or repairs are to be undertaken in any processing, handling or storage area.
11.2.10.7 The maintenance supervisor and the facility supervisor shall be informed if any repairs or maintenance pose a potential threat to product safety (i.e. pieces of electrical wire, damaged light fittings, and loose overhead fittings). When possible, maintenance is to be conducted outside processing times.
11.2.10.8 Temporary repairs, where required shall not pose a food safety risk and shall be included in the cleaning program. There shall be a plan in place to address final completion of temporary repairs in order to ensure they do not become permanent solutions.
11.2.10.9 Maintenance staff and contractors shall remove all tools and debris from any maintenance activity once it has been completed and inform the area supervisor and maintenance supervisor so appropriate hygiene and sanitation can be completed and a pre-operational inspection conducted prior to the commencement of site operations.
11.2.10.10 Equipment located over product or product conveyors shall be lubricated with food grade lubricants and their use controlled so as to minimize the contamination of the product.
11.2.10.11 Paint used in a food handling or contact zone shall be suitable for use and in good condition and shall not be used on any product contact surface.

11.2.11 Calibration

11.2.11.1 The methods and responsibility for the calibration and re-calibration of measuring, test and inspection equipment used for monitoring activities outlined in pre-requisite program, food safety plans and 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.
11.2.11.2 Procedures shall be documented and implemented to address the disposition of potentially affected products should measuring, test and inspection equipment be found to be out of calibration state.
11.2.11.3 Calibrated measuring, test and inspected equipment shall be protected from damage and unauthorized adjustment.
11.2.11.4 Equipment shall be calibrated against national or international reference standards and methods or to accuracy appropriate to its use. In cases where standards are not available, the site shall provide evidence to support the calibration reference method applied.
11.2.11.5 Calibration shall be performed according to regulatory requirements and/or to the equipment manufacturers recommended schedule.
11.2.11.6 Calibration records shall be maintained.

11.2.12 Pest Prevention

11.2.12.1 The methods and responsibility for pest prevention shall be documented and effectively implemented. The premises, its surrounding areas, storage facilities, machinery and equipment shall be kept free of waste or accumulated debris so as not to attract pests and vermin.
11.2.12.2 Identified pest activity shall not present a risk of contamination to food products, raw materials or packaging.
11.2.12.3 Food products, raw materials or packaging that are found to be contaminated by pest activity shall be effectively disposed of, and the source of pest infestation investigated and resolved. Records shall be kept of the disposal, investigation, and resolution.
11.2.12.4 The pest prevention program 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; 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 bait stations set; vii. List the chemicals used (they 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.
11.2.12.5 Inspections for pest activity shall be undertaken on a regular basis by trained personnel and the appropriate action taken if pests are present.
11.2.12.6 Records of all pest control applications shall be maintained.
11.2.12.7 Pesticides and other toxic chemicals shall be clearly labeled and stored as described in element 11.6.5 and handled and applied by properly trained personnel. They shall be used by or under the direct supervision of trained personnel with a thorough understanding of the hazards involved, including the potential for the contamination of food and food contact surfaces.
11.2.12.8 Pest contractors shall be: i. 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 2.3.3) which will include and maintain 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; and vi. Provide a written report of their findings and the inspections and treatments applied.
11.2.12.9 The site shall dispose of unused pest control chemicals and empty containers in accordance with regulatory requirements and ensure that: i. Empty chemical containers are not reused; ii. Empty containers are labeled, isolated and securely stored while awaiting collection; and iii. Unused and obsolete chemicals are stored under secure conditions while waiting authorized disposal by an approved vendor.

11.2.13 Cleaning and Sanitation

11.2.13.1 The methods and responsibility for the cleaning of the food handling and processing equipment and environment, storage areas, staff amenities and toilet facilities shall be documented and implemented. Consideration shall be given to: i. What is to be cleaned; ii. How it is to be cleaned; iii. When it is to be cleaned; iv. Who is responsible for the cleaning; v. Methods used to confirm and record the correct concentrations of detergents and sanitizers, and vi. The responsibility and methods used to verify the effectiveness of the cleaning and sanitation program.
11.2.13.2 Provision shall be made for the effective cleaning of processing equipment, utensils and protective clothing.
11.2.13.3 Suitably equipped areas shall be designated for cleaning product containers, knives, cutting boards and other utensils and for cleaning of protective clothing used by staff. These cleaning operations shall be controlled so as not to interfere with manufacturing operations, equipment or product. Racks and containers for storing cleaned utensils shall be provided as required.
11.2.13.4 Cleaning in place (CIP) systems where used shall not pose a chemical contamination risk to raw materials, ingredients or product. CIP parameters critical to assuring effective cleaning shall be defined, monitored and recorded (e.g., chemical and concentration used, contact time and temperature). CIP equipment including spray balls shall be maintained and modifications to CIP equipment shall be validated. Personnel engaged in CIP activities shall be effectively trained.
11.2.13.5 Pre-operational inspections shall be conducted following cleaning and sanitation operations to ensure food processing areas, product contact surfaces, equipment, staff amenities and sanitary facilities and other essential areas are clean before the commencement of production. Pre-operational inspections shall be conducted by qualified personnel.
11.2.13.6 Staff amenities, sanitary facilities and other essential areas shall be inspected by qualified personnel to ensure the areas are clean, at a defined frequency.
11.2.13.7 "The responsibility and methods used to verify the effectiveness of the cleaning procedures shall be documented and implemented. A verification schedule shall be prepared.
11.2.13.8 Detergents and sanitizers shall be suitable for use in a food manufacturing environment, labeled according to regulatory requirements, and purchased in accordance with applicable legislation. The organization shall ensure: i. The site maintains a list of chemicals approved for use; ii. An inventory of all chemicals purchased and used shall be maintained; iii. Detergents and sanitizers are stored as outlined in element 11.6.4; iv. Safety Data Sheets (SDS) are provided for all detergents and sanitizers purchased; and v. Only trained staff handles sanitizers and detergents.
11.2.13.9 Detergents and sanitizers that have been mixed for use shall be correctly mixed according to manufacturers instructions, stored in containers that are suitable for use, and clearly identified. Mix concentrations shall be verified and records maintained.
11.2.13.10 The site shall dispose of unused detergents and sanitizers and empty containers in accordance with regulatory requirements and ensure that: i. Empty detergent and sanitizer containers are appropriately cleaned, treated and labeled before use; ii. Empty detergent and sanitizer containers are labeled, isolated and securely stored while awaiting collection; and iii. Unused and obsolete detergents and sanitizers are stored under secure conditions while waiting authorized disposal by an approved vendor.
11.2.13.11 A record of pre-operational hygiene inspections, cleaning and sanitation activities, and verification activities shall be maintained.

11.3 Personnel Hygiene and Welfare

11.3.1 Personnel

11.3.1.1 Personnel suffering from infectious diseases or are carriers of any infectious disease shall not engage in product handling or processing operation.
11.3.1.2 The site shall have measures in place to prevent contact of materials, ingredients, food packaging, food, or food contact surfaces from any bodily fluids from open wounds, coughing, sneezing, spitting, or any other means. In the event of an injury which causes spillage of bodily fluid, properly trained employee shall ensure that all affected areas including handling and processing areas have been adequately cleaned and that all materials and products have been quarantined and disposed of.
11.3.1.3 Personnel with exposed cuts, sores or lesions shall not be engaged in handling or processing products or handling primary packaging materials or food contact surfaces. Minor cuts or abrasions on exposed parts of the body shall be covered with a colored bandage containing a metal strip or an alternative suitable waterproof and colored dressing.
11.3.1.4 Smoking, chewing, eating, drinking or spitting is not permitted in any food processing or food handling areas is not permitted in areas where product is produced, stored, or otherwise exposed. Drinking of water is permissible only under conditions that prevent contamination or other food safety risk from occuring. Drinking water containers in production and storage areas shall be stored in clear, covered containers, and n designated areas away from raw materials, packaging, or equipment.

11.3.2 Hand Washing

11.3.2.1 Hand wash basins shall be provided adjacent to all personnel access points and in accessible locations throughout food handling and processing areas as required.
11.3.2.2 Hand wash basins shall be constructed of stainless steel or similar non-corrosive material and as a minimum supplied with: i. A potable water supply at an appropriate temperature; ii. Liquid soap contained within a fixed dispenser; iii. Paper towels in a hands free cleanable dispenser; and iv. A means of containing used paper towels.
11.3.2.3 The following additional facilities shall be provided in high risk areas: i. Hands free operated taps; and ii. Hand sanitizers.
11.3.2.4 A sign instructing people to wash their hands, and in appropriate languages, shall be provided in a prominent position.
11.3.2.5 Personnel shall have clean hands and hands shall be washed by all personnel, including staff, contractors and visitors: i. On entering food handling or processing areas; ii. After each visit to a toilet; iii. After using a handkerchief; iv. After smoking, eating or drinking; and v. After handling wash down hoses, dropped product or contaminated material.
11.3.2.6 When gloves are used, personnel shall maintain the hand washing practices outlined above.

11.3.3 Clothing

11.3.3.1 The facility shall undertake a risk analysis to ensure that the clothing and hair policy protects materials, food and food contact surfaces from unintentional microbiological or physical contamination.
11.3.3.2 Clothing worn by staff engaged in handling food shall be maintained, stored, laundered and worn so as not to present a contamination risk to products.
11.3.3.3 Clothing, including shoes, shall be clean at the commencement of each shift and maintained in a serviceable condition.
11.3.3.4 Excessively soiled uniforms shall be changed or replaced where they present a product contamination risk.
11.3.3.5 Disposable gloves and aprons shall be changed after each break, upon re-entry into the processing area and when damaged. Non-disposable aprons and gloves shall be cleaned and sanitized as required and when not in use stored on racks provided in the processing area or designated sealed containers in personnel lockers and not on packaging, ingredients, product or equipment.

11.3.4 Jewelry and Personal Effects

11.3.4.1 Jewelry and other loose objects shall not be worn or taken into a food handling or processing operation or any area where food is exposed. The wearing of plain bands with no stones and prescribed medical alert bracelets can be permitted, however the site will need to consider their customer requirements and the applicable food legislation.

11.3.5 Visitors

11.3.5.1 All visitors, including management and maintenance staff, shall wear suitable clothing and footwear when entering any food processing or handling area.
11.3.5.2 All visitors shall be required to remove jewelry and other loose objects.
11.3.5.3 Visitors exhibiting visible signs of illness shall be prevented from entering areas in which food is handled or processed.
11.3.5.4 Visitors shall enter and exit food handling areas through the proper staff entrance points and comply with all hand washing and personnel practice requirements.
11.3.5.5 All visitors shall be trained in the facility's food safety and hygiene procedures before entering into any food processing or handling areas, or shall be escorted at all times in food processing, handling and storage areas.

11.3.6 Staff Amenities

11.3.6.1 Staff amenities supplied with appropriate lighting and ventilation shall be made available for the use of all persons engaged in the handling and processing of product.

11.3.7 Change Rooms

11.3.7.1 Facilities shall be provided to enable staff and visitors to change into and out of protective clothing as required.
11.3.7.2 Change rooms shall be provided for staff engaged in the processing of high risk foods or processing operations in which clothing can be soiled.
11.3.7.3 Provision shall be made for staff to store their street clothing and personal items separate from food contact zones and food and packaging storage areas.
11.3.7.4 Where required, a sufficient number of showers shall be provided for use by staff.

11.3.8 Laundry

11.3.8.1 Provision shall be made for the laundering and storage of clothing worn by staff engaged in high risk processes and for staff engaged in processing operations in which clothing can be heavily soiled.

11.3.9 Sanitary Facilities

11.3.9.1 Toilet rooms shall be: i. Designed and constructed so that they are accessible to staff and separate from any processing and food handling operations; ii. Accessed from the processing area 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.
11.3.9.2 Sanitary drainage shall not be connected to any other drains within the premises and shall be directed to a septic tank or a sewerage system in accordance with regulations.
11.3.9.3 Hand wash basins shall be provided immediately outside or inside the toilet room and designed as outlined in 11.3.2.2.

11.3.10 Lunch Rooms

11.3.10.1 Separate lunch room facilities shall be provided away from a food contact/handling zone.
11.3.10.2 Lunch room facilities shall be: i. Ventilated and well lit; ii. Provided with adequate tables and seating to cater for the maximum number of staff at one sitting; iii. Equipped with a sink serviced with hot and cold potable water for washing utensils; iv. Equipped with refrigeration and heating facilities enabling them to store or heat food and to prepare non-alcoholic beverages if required; and v. Kept clean and free from waste materials and pests.
11.3.10.3 Where outside eating areas are provided, they should be kept clean and free from waste materials and maintained in a manner that minimizes the potential for introduction of contamination into site and pest attraction.
11.3.10.4 Signage in appropriate languages instructing people to wash their hands before entering the food processing areas shall be provided in a prominent position in lunch rooms and at lunch room exits, and in outside eating areas, if applicable.

11.4 Personnel Processing Practices

11.4.1 Staff Engaged in Food Handling and Processing Operations

11.4.1.1 All personnel engaged in any food handling, preparation or processing operations shall ensure that products and materials are handled and stored in such a way as to prevent damage or product contamination. They shall comply with the following processing practices: i. Personnel entry to processing areas shall be through the personnel access doors only; ii. All doors are to be kept closed. Doors shall not be left open for extended periods when access for waste removal or receiving of product/ingredient/packaging is required; iii. Packaging material, product, and ingredients shall be kept in appropriate containers as required and off the floor; iv. Waste shall be contained in the bins identified for this purpose and removed from the processing area on a regular basis and not left to accumulate; v. Staff shall not eat or taste any product being processed in the food handling/contact zone, except as noted in element 11.4.1.2; vi. The wearing of false fingernails, false eyelashes, eyelash extensions, long nails or fingernail polish is not permitted when handling exposed food; vii. Hair restraints are used where product is exposed.
11.4.1.2 In circumstances where it is necessary to undertake sensory evaluations in a food handling/contact zone, the site shall implement proper controls and procedures to ensure: i. Food safety is not compromised; ii. Sensory evaluations are conducted by authorized personnel only; iii. A high standard of personal hygiene is practiced by personnel conducting sensory evaluations; iv. Sensory evaluations are conducted in areas equipped for the purpose; and v. Equipment used for sensory evaluations is sanitized, maintained and stored separate from processing equipment.
11.4.1.3 All wash down hoses shall be stored on hose racks after use and not left on the floor.

11.5 Water, Ice, and Air Supply

11.5.1 Water Supply

11.5.1.1 Adequate supplies of potable water drawn from a known clean source shall be provided for use during processing operations, as an ingredient and for cleaning the premises and equipment.
11.5.1.2 Supplies of hot and cold water shall be provided as required to enable the effective cleaning of the premises and equipment.
11.5.1.3 The delivery of water within the premises shall ensure potable water is not contaminated.
11.5.1.4 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; Iii. Hoses, taps, or other similar sources of possible contamination are designed to prevent back flow or back siphonage.
11.5.1.5 Where water is stored on site, storage facilities shall be adequately designed, constructed and maintained to prevent contamination.

11.5.2 Water Treatment

11.5.2.1 Water treatment methods, equipment and materials, if required, shall be designed, installed and operated to ensure water receives an effective treatment
11.5.2.2 Water treatment equipment shall be monitored regularly to ensure it remains serviceable.
11.5.2.3 Treated water shall be regularly monitored to ensure it meets the indicators specified.
11.5.2.4 Water used in as an ingredient in processing, or in cleaning and sanitizing equipment, shall be tested, and if required, treated to maintain potability (refer to element 11.5.2.1).

11.5.3 Ice Supply

11.5.3.1 Ice provided for use during processing operations or as a processing aid or an ingredient shall comply with 11.5.4.1.
11.5.3.2 Ice rooms and receptacles shall be constructed of materials as outlined in elements 11.2.1, 11.2.2 and 11.2.3 and designed to minimize contamination of the ice during storage and distribution.

11.5.4 Monitoring Water Microbiology and Quality

11.5.4.1 Water shall comply with local, national or internationally recognized potable water microbiological and quality standards as required when used for: i. washing, thawing and treating food; ii. handwashing; iii. to convey food; iv. as an ingredient or food processing aid; v. cleaning food contact surfaces and equipment; vi. the manufacture of ice; or vii. the manufacture of steam that will come into contact with food or used to heat water that will come in contact with food.
11.5.4.2 Microbiological analysis of the water and ice 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 at sources supplying water for the process or cleaning from within the facility. The frequency of analysis shall be risk-based, and at a minimum annually.
11.5.4.3 Water and ice shall be analyzed using reference standards and methods.

11.5.5 The Quality of Air and Other Gasses

11.5.5.1 Compressed air or other gases (e.g., nitrogen, carbon dioxide) that contacts food or food contact surfaces shall be clean and present no risk to food safety.
11.5.5.2 Compressed air systems, and systems used to store or dispense other gases used in the manufacturing process that come into contact with food or food contact surfaces shall be maintained and regularly monitored for quality and applicable food safety hazards.

11.6 Storage and Transport

11.6.1 Storage and Handling of Goods

11.6.1.1 The site shall document and implement an effective storage plan that allows for the safe, hygienic storage of raw materials (frozen, chilled, and ambient), ingredients, packaging materials, equipment, and chemicals.
11.6.1.2 The responsibility and methods for ensuring effective stock rotation principles are applied shall be documented and implemented.
11.6.1.3 Procedures are in place to ensure that all ingredients, materials, work-in-progress, rework, and finished product are utilized within their designated shelf-life.
11.6.1.4 Equipment storage rooms shall be designed and constructed to allow for the hygenic and efficient storage of equipment and containers.
11.6.1.5 Where goods described in 11.6.2 to 11.6.4 are held under temporary or overflow conditions that are not designed for the safe storage of goods, a risk analysis shal be undertaken to ensure there is no risk to the integrity of those goods or contamination or adverse effect on food safety.
11.6.1.6 Records shall be available to validate alternate or temporary control measures for the storage of raw materials, ingredients, packaging materials, equipment, chemicals, or finished products.

11.6.2 Cold Storage, Freezing and Chilling of Foods

11.6.2.1 The site shall provide confirmation of the effective operational performance of freezing, chilling and cold storage facilities. Chillers, blast freezers and cold storage rooms shall be designed and constructed to allow for the hygienic and efficient refrigeration of food and easily accessible for inspection and cleaning.
11.6.2.2 Sufficient refrigeration capacity shall be available to chill, freeze, store chilled or store frozen the maximum anticipated throughput of product with allowance for periodic cleaning of refrigerated areas.
11.6.2.3 Discharge from defrost and condensate lines shall be controlled and discharged to the drainage system.
11.6.2.4 Freezing, chilling and cold storage rooms shall be fitted with temperature monitoring equipment and located so as to monitor the warmest part of the room and be fitted with a temperature measurement device that is easily readable and accessible.
11.6.2.5 Loading and unloading docks shall be designed to protect the product during loading and unloading.

11.6.3 Storage of Dry Ingredients, Packaging, and Shelf Stable Packaged Goods

11.6.3.1 Rooms used for the storage of product ingredients, packaging, and other dry goods shall be located away from wet areas and constructed to protect the product from contamination and deterioration.
11.6.3.2 Racks provided for the storage of packaging shall be constructed of impervious materials and designed to enable cleaning of the floors and the storage room. Storage areas shall be constructed to prevent packaging from becoming a harborage for pests or vermin.
11.6.3.3 Vehicles used in food contact, handling or processing zones or in cold storage rooms shall be designed and operated so as not to present a food safety hazard.

11.6.4 Storage of Hazardous Chemicals and Toxic Substances

11.6.4.1 Hazardous chemicals and toxic substances with the potential for food contamination shall be stored so as not to present a hazard to staff, product, packaging, product handling equipment or areas in which the product is handled, stored or transported.
11.6.4.2 Processing utensils and packaging shall not be stored in areas used to store hazardous chemicals and toxic substances.
11.6.4.3 Daily supplies of chemicals used for continuous sanitizing of water or as a processing aid, or for emergency cleaning of food processing equipment or surfaces in food contact zones, may be stored within or in close proximity to a processing area provided access to the chemical storage facility is restricted to authorized personnel.
11.6.4.4 Pesticides, rodenticides, fumigants and insecticides shall be stored separate from sanitizers and detergents. All chemicals shall be stored in their original containers, or in clearly labelled and suitable secondary containers if allowed by applicable legislation.
11.6.4.5 Hazardous chemical and toxic substance storage facilities shall: i. Be compliant with national and local legislation and designed such that there is no cross-contamination between chemicals; ii. Be adequately ventilated; iii. Be provided with appropriate signage indicating the area is a hazardous storage area; iv. Be secure and lockable to restrict access only to those personnel with formal training in the handling and use of hazardous chemicals and toxic substances; v. Have instructions on the safe handling of hazardous chemicals and toxic substances readily accessible to staff; vi. Be equipped with a detailed and up-to-date inventory of all chemicals contained in the storage facility; vii. Have suitable first aid equipment and protective clothing available in close proximity to the storage area; viii. In the event of a hazardous spill, be designed such that spillage and drainage from the area is contained; and ix. Be equipped with spillage kits and cleaning equipment.

11.6.5 Loading, Transport, and Unloading Practices

11.6.5.1 The practices applied during loading, transport and unloading of food shall be documented, implemented and designed to maintain appropriate storage conditions and product integrity. Foods shall be loaded, transported and unloaded under conditions suitable to prevent cross contamination.

11.6.6 Loading

11.6.6.1 Vehicles (e.g. trucks/vans/containers) used for transporting food 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 product.
11.6.6.2 Loading practices shall be designed to minimize unnecessary exposure of the product to conditions detrimental to maintaining the product and package integrity during loading and transport.
11.6.6.3 Vehicles (e.g. trucks/vans/containers) shall be secured from tampering using a seal or other agreed upon, acceptable device or system.

11.6.7 Transport

11.6.7.1 Refrigerated units shall maintain the food at required temperatures and the unit’s temperature settings shall be set, checked and recorded before loading and product temperatures recorded at regular intervals during loading as appropriate.
11.6.7.2 The refrigeration unit shall be operational at all times and checks completed of the unit’s operation, the door seals and the storage temperature checked at regular intervals during transit.

11.6.8 Unloading

11.6.8.1 Prior to opening the doors, the refrigeration unit’s storage temperature settings and operating temperature shall be checked and recorded. Unloading shall be completed efficiently and product temperatures shall be recorded at the commencement of unloading and at regular intervals during unloading.
11.6.10.2 Unloading practices shall be designed to minimize unnecessary exposure of the product to conditions detrimental to maintaining the product and package integrity.

11.7 Separation of Functions

11.7.1 Process Flow

11.7.1.1 The process flow shall be designed to prevent cross contamination and organized so there is a continuous flow of product through the process. The flow of personnel shall be managed such that the potential for contamination is minimized.

11.7.2 Receipt of Raw and Packaging Materials and Ingredients

11.7.2.1 Dry ingredients and packaging shall be received and stored separately from frozen and chilled raw materials to ensure there is no cross contamination. Unprocessed raw materials shall be received and segregated to ensure there is no cross contamination.

11.7.3 Thawing of Food

11.7.3.1 Thawing of food shall be undertaken in equipment and rooms appropriate for the purpose.
11.7.3.2 Equipment for water thawing shall be continuous flow to ensure the water exchange rate and temperature does not contribute to product deterioration or contamination. Water overflow shall be directed into the floor drainage system and not onto the floor.
11.7.3.3 Air thawing facilities shall be designed to thaw food under controlled conditions at a rate and temperature that does not contribute to product deterioration or contamination.
11.7.3.4 Provision is to be made for the containment and regular disposal of used cartons and packaging from thawed product so that there is no risk to the product.

11.7.4 High Risk Processes

11.7.4.1 "The processing of high risk food shall be conducted under controlled conditions such that sensitive areas in which high risk food has undergone a “kill” step, a “food safety intervention” or is subject to post process handling, are protected/segregated from other processes, raw materials or staff who handle raw materials to ensure cross contamination is minimized.
11.7.4.2 Areas in which high risk processes are conducted shall only be serviced by staff dedicated to that function.
11.7.4.3 Staff access points shall be located, designed and equipped to enable staff to don distinctive protective clothing and to practice a high standard of personal hygiene to prevent product contamination.
11.7.4.4 Staff engaged in high risk areas shall change into clean clothing or don temporary protective outerwear when entering high risk areas.
11.7.4.5 Product transfer points shall be located and designed so as not to compromise high risk segregation and to minimize the risk of cross contamination.

11.7.5 Control of Foreign Matter Contamination

11.7.5.1 The responsibility and methods used to prevent foreign matter contamination of the product shall be documented, implemented and communicated to all staff.
11.7.5.2 Inspections shall be performed to ensure plant and equipment remains in good condition, equipment has not become detached or deteriorated and is free from potential contaminants.
11.7.5.3 All glass objects or similar material in food handling/contact zones shall be listed in a glass register including details of their location.
11.7.5.4 Containers, equipment and other utensils made of glass, porcelain, ceramics, laboratory glassware or other like material (except where the product is contained in packaging made from these materials, or measurement instruments with glass dial covers or MIG thermometers required under regulation) shall not be permitted in food processing /contact zones.
11.7.5.5 Regular inspections of food handling/contact zones shall be conducted to ensure they are free of glass or other like material and to establish changes to the condition of the objects listed in the glass register.
11.7.5.6 Glass instrument dial covers on processing equipment and MIG thermometers shall be inspected at the start and finish of each shift to confirm they have not been damaged.
11.7.5.7 Wooden pallets and other wooden utensils used in food handling/contact zones shall be dedicated for that purpose, clean, maintained in good order. Their condition is subject to regular inspection.
11.7.5.8 Loose metal objects on equipment, equipment covers and overhead structures shall be removed or tightly fixed so as not to present a hazard.
11.7.5.9 Knives and cutting instruments used in processing and packaging operations shall be controlled, and kept clean and well maintained. Snap-off blades shall not be used in manufacturing or storage areas.

11.7.6 Detection of Foreign Objects

11.7.6.1 The responsibility, methods and frequency for monitoring, maintaining, calibrating and using screens, sieves, filters or other technologies to remove or detect foreign matter shall be documented and implemented.
11.7.6.2 Metal detectors or other physical contaminant detection technologies shall be routinely monitored, validated and verified for operational effectiveness. The equipment shall be designed to isolate defective product and indicate when it is rejected.
11.7.6.3 Records shall be maintained of the inspection of foreign object detection devices and of any products rejected or removed by them. Records shall include any corrective actions resulting from the inspections.

11.7.7 Managing Foreign Matter Contamination Incidents

11.7.7.1 In all cases of foreign matter contamination, the affected batch or item shall be isolated, inspected, reworked or disposed of.
11.7.7.2 In circumstances where glass or similar material breakage occurs, the affected area is to be isolated, cleaned and thoroughly inspected (including cleaning equipment and footwear) and cleared by a suitably responsible person prior to the commencement of operations.

11.8 On-Site Laboratories

11.8.1 Location

11.8.1.1 On site laboratories conducting chemical and microbiological analysis that may pose a risk to product safety, shall be located separate from any food processing or handling activity and designed to limit access only to authorized personnel.
11.8.1.2 Provisions shall be made to isolate and contain all laboratory waste held on the premises and manage it separately from food waste. Laboratory waste water outlet shall as a minimum be down stream of drains that service food processing and handling areas.
11.8.1.3 Signage shall be displayed identifying the laboratory area as a restricted area accessible only by authorized personnel.

11.9 Waste Disposal

11.9.1 Dry and Liquid Waste Disposal

11.9.1.1 The responsibility and methods used to collect and handle dry, wet and liquid waste and store prior to removal from the premises shall be documented and implemented.
11.9.1.2 Waste shall be removed on a regular basis and not build up in food handling or processing areas. Designated waste accumulation areas shall be maintained in a clean and tidy condition until such time as external waste collection is undertaken.
11.9.1.3 Trolleys, vehicles waste disposal equipment, collection bins and storage areas shall be maintained in a serviceable condition and cleaned and sanitized regularly so as not to attract pests and other vermin.
11.9.1.4 Adequate provision shall be made for the disposal of all solid processing waste including trimmings, inedible material and used packaging.
11.9.1.5 Where applicable, a documented procedure shall be in place for the controlled disposal of trademarked materials. Where a contracted disposal service is used, the disposal process shall be reviewed regularly to confirm compliance.
11.9.1.6 Inedible waste designated for animal feed shall be stored and handled so as to not cause a risk to the animal or to further processing.
11.9.1.7 Waste held on site prior to disposal shall be stored in a separate storage area and suitably pest proofed and contained so as not to present a hazard.
11.9.1.8 Adequate provision shall be made for the disposal of all liquid waste from processing and food handling areas. Liquid waste shall be either removed from the processing environment continuously or held in a designated storage area in lidded containers prior to disposal so as not to present a hazard.
11.9.1.9 Reviews of the effectiveness of waste management will form part of daily hygiene inspections and the results of these inspections shall be included in the relevant hygiene reports.

11.10 Exterior

11.10.1 Grounds and Roadways

11.10.1.1 Measures shall be established to maintain a suitable external environment, and the effectiveness of the established measures shall be monitored and periodically reviewed.
11.10.1.2 The grounds and area surrounding the premises shall be maintained to minimize dust and be kept free of waste, accumulated debris or standing water so as not to attract pests and vermin.
11.10.1.3 Paths, roadways and loading and unloading areas shall be maintained so as not to present a hazard to the food safety operation of the premises.
11.10.1.4 Paths, roadways, loading and unloading areas shall be adequately drained to prevent ponding of water. Drains shall be separate from the facility drainage system and regularly cleared of debris.
11.10.1.5 Surroundings shall be kept neat and tidy and not present a hazard to the hygienic and sanitary operation of the premises.
11.10.1.6 Paths from amenities leading to facility entrances are required to be effectively sealed

Completion

Closing Meeting
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Hebert - SQF System Elements for Manufacturing - SQF Code, Edition 8

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SQF Code, edition 8

Facility Description

Auditor Recommendation

2.1 Management Commitment

2.1.1 Food Safety Policy (Mandatory)

2.1.2 Management Responsibility (Mandatory)

2.1.3 Management Review (Mandatory)

2.1.4 Complaint Management (Mandatory)

2.1.5 Crisis Management Planning

2.2 Document Control and Records

2.2.1 Food Safety Management System (Mandatory)

2.2.2 Document Control (Mandatory)

2.2.3 Records (Mandatory)

2.3 Specification and Product Development

2.3.1 Product Development and Realization

2.3.2 Raw and Packaging Materials

2.3.3 Contract Service Providers

2.3.4 Contract Manufacturers

2.3.5 Finished Product Specifications

2.4 Food Safety System

2.4.1 Food Legislation (Mandatory)

2.4.2 Good Manufacturing Practices (Mandatory)

2.4.3 Food Safety Plan (Mandatory)

2.4.4 Approved Supplier Program (Mandatory)

2.4.5 Non-conforming Product or Equipment

2.4.6 Product Rework

2.4.7 Product Release (Mandatory)

2.4.8 Environmental Monitoring

2.5 SQF System Verification

2.5.1 Validation and Effectiveness (Mandatory)

2.5.2 Verification Activities (Mandatory)

2.5.3 Corrective and Preventative Action (Mandatory)

2.5.4 Product Sampling, Inspection and Analysis

2.5.5 Internal Audits and Inspections (Mandatory)

2.6 Product Identification, Trace, Withdrawal and Recall

2.6.1 Product Identification (Mandatory)

2.6.2 Product Trace (Mandatory)

2.6.3 Product Withdrawal and Recall (Mandatory)

2.7 Food Defense and Food Fraud

2.7.1 Food Defense Plan (Mandatory)

2.7.2 Food Fraud

2.8 Allergen Management

2.8.1 Allergen Management for Food Manufacturing (Mandatory)

2.8.2 Allergen Management for Pet Food Manufacturing (Mandatory)

2.9 Training

2.9.1 Training Requirements

2.9.2 Training Program (Mandatory)

2.9.3 Instructions

2.9.4 HACCP Training Requirements

2.9.5 Language

2.9.6 Refresher Training

2.9.7 Training Skills Register

11.1 Site Location and Construction

11.1.1 Premises Location and Approval

11.2 Construction of Premises and Equipment

11.2.1 Materials and Surfaces

11.2.2 Floors, Drains, and Waste Traps

11.2.3 Walls, Partitions, Floors and Ceilings

11.2.4 Stairs, Catwalks and Platforms

11.2.5 Lightings and Light Fittings

11.2.6 Inspection / Quality Control Area

11.2.7 Dust, Insect, and Pest Proofing

11.2.8 Ventilation

11.2.9 Equipment, Utensils, and Protective Clothing

11.2.10 Premises and Equipment Maintenance

11.2.11 Calibration

11.2.12 Pest Prevention

11.2.13 Cleaning and Sanitation

11.3 Personnel Hygiene and Welfare

11.3.1 Personnel

11.3.2 Hand Washing

11.3.3 Clothing

11.3.4 Jewelry and Personal Effects

11.3.5 Visitors

11.3.6 Staff Amenities

11.3.7 Change Rooms