SQF Checklist: Dietary Supplement Manufacturing - Edition 9

Opening Meeting | People Present at the Opening Meeting (Please list names and roles in the following format Name: Role separated by comas)

Closing Meeting | People Present at the Closing Meeting (Please list names and roles in the following format Name: Role separated by comas)

Facility Description | Auditor Description of Facility (Please provide facility description include # of employees, size, production schedule, general layout, and any additional pertinent details

Auditor Recommendation

2.1.1.1 Senior site management shall prepare and implement a policy statement that outlines at a minimum the commitment of all site management to:

• Supply safe dietary supplements

• Establish and maintain a food safety culture within the sit

• Establish and continually improve the site’s food safety management system

• Comply with customer and regulatory requirements to supply safe dietary supplements.

• The policy statement shall be signed by the senior site manager and displayed in prominent position

• Effectively communicated to all site personnel in the language(s) understood by all site personnel

2.1.1.2 Senior site management shall lead and support a food safety culture within the site that ensures at a minimum

• The establishment, documentation, and communication to all relevant staff of food safety objectives and performance measures

• Adequate resources are available to meet food safety objectives and performance measures and resource allocation and responsibility ensures regulation and any associated licensing is maintained and aligned with the SQF System

• Food safety practices and all applicable requirements of the SQF System are adopted and maintained

• Staff are informed and aware of their food safety and regulatory responsibilities

• Staff are aware of their role in meeting the requirements of the SQF Food Safety Code: Dietary Supplements Manufacturing and are held accountable for meeting these requirements;

• Staff are positively encouraged and required to notify management about actual or potential food safety issues

• Staff are empowered to act to resolve food safety issues within their scope of work

2.1.1.3

• The reporting structure shall identify and describe site personnel with specific responsibilities for tasks within the food safety management system. It shall clearly indicate the designated quality control person or other resource responsible for regulations.

• Job descriptions for key employees shall be documented and include a provision to cover for the absence of key personnel.

• Site management shall ensure departments and operations are appropriately staffed and organizationally aligned to meet food safety objectives.

2.1.1.4 Senior site management shall designate a primary and substitute SQF practitioner for each site with responsibility and authority to:

• Oversee the development, implementation, review, and maintenance of the SQF System;

• Ensure all regulatory requirements are being met;

• Take appropriate action to ensure the integrity of the SQF System;

• Communicate to relevant personnel all information essential to ensure the effective implementation and maintenance of the SQF System.

2.1.1.5 The primary and substitute SQF practitioner shall:

• Be employed by the site;

• Hold a position of responsibility related to the management of the site's SQF System;

• Have completed a HACCP training course;

• Be competent to implement and maintain HACCP based food safety plans;

• Have an understanding of the SQF Food Safety Code: Food Manufacturing and the requirements to implement and maintain an SQF System relevant to the site's scope of certification

2.1.2.1 The SQF System shall be reviewed by senior site management at least annually and include:

• Changes to food safety management system documentation (policies, procedures, specifications, food safety plan);

• Food safety culture performance;

• Food safety objectives and performance measures;

• Corrective and preventative actions and trends in findings from internal and external audits, customer complaints, and verification and validation activities;

• Hazard and risk management system;

• Follow-up action items from previous management reviews. Records of all management reviews and updates shall be maintained.

2.1.3.1 The methods and responsibility for handling and investigating the cause and resolution of complaints that may result in a food safety issue from commercial customers, consumers, and authorities, arising from products manufactured or handled on-site or co-manufactured, shall be documented and implemented. It shall minimally include:

• The qualified person responsible for reviews, approvals, and follow-up activitie

• Required actions when complaints determine that products are potentially not meeting finished product specifications.

2.2.1.1 The methods and procedures the site uses to meet the requirements of the SQF Food Safety Code: Dietary Supplements Manufacturing shall be maintained in electronic and/or hard copy documentation. They will be made available to relevant staff and include:

• A summary of the organization’s food safety policies and the methods it will apply to meet the requirements of this standard;

• The food safety policy statement and organization chart;

• The processes and products included in the scope of certification;

• Food safety and dietary supplement regulations that apply to the manufacturing site and the country(ies) of sale (if known);

• Raw material, ingredient, packaging, and finished product specifications;

• Production and process control procedures and specifications supporting or impacting regulatory limits/claims and food safety;

• Other documentation necessary to support the development, implementation, maintenance, and control of the SQF System.

2.3.1.2 New product formulations, manufacturing processes, and the fulfillment of product requirements shall be established, validated, and verified by site trials and product testing as required to ensure:

• Product safety, regulatory limits (e.g., potency, strength, homogeneity, and purity), and claims are maintained to the end of the shelf life;

• Manufacturing processes and instructions ensure product homogeneity, flushing sequences, special instructions, and cleanout procedures;

• Product formulations are developed by authorized persons;

• Shelf life studies account for pre-consumer handling and storage requirements including the establishment of “use by,” “best before dates,” or equivalent terminology;

• Instructions for consumer preparation, where applicable, and storage and handling requirement

2.3.2.9 Finished product specifications shall be documented, current, approved by the site and their customer, accessible to relevant staff, and shall include, where applicable:

• Microbiological, chemical, and physical limits

• Purity, strength, and composition supporting regulatory and quality label claim

• Limits or levels of possible adulterants;

• Labeling and packaging requirements

• Storage condition

2.3.3.2 The site shall establish a method to determine the food safety risk level of contract manufactured product and shall document the risk. The site shall ensure that:

• Products and processes of co-manufacturers that are considered high-risk have undergone an audit by the site or third-party agency to confirm compliance with the SQF Food Safety Code: Dietary Supplements Manufacturing and regulatory and customer requirements;

• Products and processes of co-manufacturers that are considered low risk meet the requirements of the SQF Food Safety Code: Dietary Supplements Manufacturing, or other GFSI benchmarked certification programs, and regulatory and customer requirements; and

• Changes to contractual agreements are approved by both parties and communicated to relevant personnel.

2.3.4.2 The approved supplier program shall be based on the past performance of a supplier and the risk level of the raw materials, ingredients, processing aids, packaging, and services supplied, and shall contain at a minimum:

• Agreed specifications (refer to 2.3.2)

• Reference to the level of risk applied to raw materials, ingredients, packaging, and services from the approved supplier

• A summary of the food safety controls implemented by the approved supplier

• Methods for granting approved supplier status

• Methods and frequency of monitoring approved suppliers

• Details of the certificates of conformance, if required;

• Methods and frequency of reviewing approved supplier performance and status

2.4.1.1 The site shall ensure that, at the time of delivery to its customer, the dietary supplement supplied shall comply with the legislation that applies to the dietary supplement and its production in the country of manufacture, and the country of use or sale (if known). This includes:

• Compliance with federal or national legislative requirements applicable to maximum residue limits, food safety, packaging, product description, net weights, nutritional, allergen, and additive labeling;

• Compliance with regulatory licensing requirements for the site and/or its suppliers and customers

• Labeling of identity preserved foods;

• Purity, strength, and composition claim

• Any other criteria listed under dietary supplement legislation and relevant established industry codes of practice.

2.4.4.1 The methods, responsibility, and criteria for sampling, inspecting, and/or analysis shall be documented and implemented. The methods applied shall ensure:

• Inspections and analyses are completed at regular intervals as required and to agreed specification and legal requirements;

• Inspections and/or testing are conducted to ensure raw materials, packaging, labels, work-in progress and finished products comply with the relevant specifications, formulation/recipes, and regulatory requirements, and are true to label;

• Sampling and testing shall be statistically based, representative of the process/batch, and ensure production and process controls are maintained to meet specifications and formulation/recipe;

• Retention samples, if required by customers or regulations, are stored and maintained for the stated shelf-life of the product.

2.4.4.2

• Product analyses shall be conducted to nationally recognized methods or company requirements, or alternative methods that are validated as equivalent to the nationally recognized methods.

• Where internal laboratories are used to conduct input, environmental, or product analyses, sampling and testing methods shall be in accordance with the applicable requirements of ISO/IEC 17025, including annual proficiency testing for staff conducting analyses.

• External laboratories shall be accredited to ISO/IEC 17025, or an equivalent international standard, and included on the site’s contract service specifications list (refer to 2.3.2.11).

2.4.5.1 The responsibility and methods outlining how to handle non-conforming product, raw material, ingredient, work-in-progress, or packaging, which is detected during receipt, storage, processing, handling, or delivery, shall be documented and implemented. The methods applied shall ensure:

• Non-conforming product is quarantined, identified, handled, and/or disposed of in a manner that minimizes the risk of inadvertent use, improper use, or risk to the integrity of finished product;

• Non-conforming product is reviewed for the nature of non-compliance, tested for conformance to specifications, and determination made by qualified personnel;

• All relevant personnel are aware of the organization’s quarantine and release requirements applicable to product placed under quarantine status

2.4.6.1 The responsibility and methods outlining how ingredients, packaging, or products are reworked shall be documented and implemented. The methods applied shall ensure:

• Reworking operations are overseen by qualified personnel;

• Reworked product is clearly identified and traceable

• Reworked product is processed in accordance with the site’s food safety plan;

• Each batch of reworked product is inspected or analyzed as required before release;

• Inspections and analyses conform to the requirements outlined in element 2.4.4.1;

• Release of reworked product conforms to element 2.4.

• Reworked product does not affect the safety or integrity of the finished product. Records of all reworking operations shall be maintained.

2.4.7.1 The methods and responsibility for releasing products shall be documented and implemented. The methods applied shall ensure the product is released:

• By authorized personnel;

• After all inspections and analyses are successfully completed and documented to verify legislative, process controls, formulation, and other established food safety controls have been met.

2.4.8.2 An environmental sampling and testing schedule shall be prepared. It shall at a minimum:

• Detail the applicable pathogens or indicator organisms to test for in that industry;

• List the number of samples to be taken and the frequency of sampling;

• Outline the locations in which samples are to be taken and the rotation of locations as needed;

• Describe the methods to handle elevated or undesirable results.

2.5.1.1 The methods, responsibility, and criteria for ensuring the effectiveness of all applicable elements of the SQF Program shall be documented and implemented. The methods applied shall validate that:

• Good Manufacturing Practices are confirmed to ensure they achieve the required results;

• Critical food safety limits are reviewed annually and re-validated or justified by regulatory standards when changes occur;

• Changes to the processes or procedures are assessed to ensure the controls are still effective. Records of all validation activities shall be maintained.

2.5.4.1 The methods and responsibility for scheduling and conducting internal audits to verify the effectiveness of the SQF System shall be documented and implemented. Internal audits shall be conducted in full and at least annually. The methods applied shall ensure:

• All applicable requirements of the SQF Food Safety Code: Dietary Supplements Manufacturing are audited per the SQF audit checklist or a similar tool;

• Objective evidence is recorded to verify compliance and/or non-compliance;

• Corrective and preventative actions of deficiencies identified during the internal audits are undertaken;

• Audit results are communicated to relevant management personnel and staff responsible for implementing and verifying corrective and preventative actions.

2.5.4.3 Regular inspections of the site and equipment shall be planned and carried out to verify Good Manufacturing Practices and facility and equipment maintenance are compliant to the SQF Food Safety Code: Dietary Supplements Manufacturing. The site shall:

• Take corrections or corrective and preventative action; and

• Maintain records of inspections and any corrective actions taken.

2.6.1.1 The methods and responsibility for identifying raw materials, ingredients, packaging, work-in-progress, process inputs, and finished products during all stages of production and storage shall be documented and implemented to ensure:

• Raw materials, ingredients, packaging, work-in-progress, process inputs, and finished products are clearly identified during all stages of receipt, production, storage, and dispatch; and

• Finished product is labeled to the customer specification and/or regulatory requirements.

2.6.1.2 Product start-up, product changeover, and packaging changeover (including labels) procedures during packing shall be documented and implemented. Procedures shall ensure that:

• The correct product is in the correct package and with the correct label;

• The changeover is inspected and approved by an authorized person; and

• Label use is reconciled and any inconsistencies investigated and resolved. Product changeover and label reconciliation records shall be maintained.

2.6.2.1 The responsibility and methods used to trace product shall be documented and implemented to ensure:

• Finished product is traceable at least one step forward to the customer and at least one step back from the process to the manufacturing supplier;

• The receipt dates of raw materials, ingredients, food contact packaging and materials, and other inputs are recorded (refer to 2.8.1.8 for traceback of allergen containing food products.);

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

• The effectiveness of the product trace system is reviewed at least annually, as part of the product recall and withdrawal review (refer to 2.6.3.2). Records of raw and packaging material receipt and use and finished product dispatch and destination shall be maintained.

2.6.3.1 The responsibility and methods used to withdraw or recall product shall be documented and implemented. The procedure shall:

• Identify those responsible for initiating, managing, and investigating a product withdrawal or recall;

• Describe the management procedures to be implemented, including sources of legal, regulatory, and expert advice, and essential traceability information;

• Outline a communication plan to inform site personnel, customers, consumers, authorities, and other essential bodies in a timely manner appropriate about the nature of the incident; and

• Ensure that SQFI, the certification body, and the appropriate regulatory authority are listed as essential organizations and notified in instances of a food safety incident of a public nature or product recall for any reason.

2.6.4.1 A crisis management plan based on the understanding of known potential dangers (e.g., flood, drought, fire, tsunami, or other severe weather events, warfare or civil unrest, computer outage, pandemic, loss of electricity or refrigeration, ammonia leak, labor strike) that can impact the site’s ability to deliver safe dietary supplements shall be documented by senior management, outlining the methods and responsibility the site shall implement to cope with such a business crisis. The crisis management

• A senior manager responsible for decision making, oversight, and initiating actions arising from a crisis management incident;

• The nomination and training of a crisis management team

• The controls implemented to ensure any responses do not compromise product safety;

• The measures to isolate and identify product affected by a response to a crisis

• The measures taken to verify the acceptability of food prior to release;

• The preparation and maintenance of a current crisis alert contact list, including supply chain customers

• Sources of legal and expert advice; and

• The responsibility for internal communications and communicating with authorities, external organizations, and media.

2.7.1.2 A food defense plan shall be documented, implemented, and maintained based on the threat assessment (refer to 2.7.1.1). The food defense plan shall meet legislative requirements as applicable and shall include at a minimum:

• The methods, responsibility, and criteria for preventing food adulteration caused by a deliberate act of sabotage or terrorist-like incident;

• The name of the senior site management person responsible for food defense;

• The methods implemented to ensure only authorized personnel have access to production equipment and vehicles, manufacturing, and storage areas through designated access points;

• The methods implemented to protect sensitive processing points from intentional adulteration;

• The measures taken to ensure the secure receipt and storage of raw materials, ingredients, packaging, equipment, and hazardous chemicals to protect them from deliberate acts of sabotage or terrorist-like incidents;

• The measures implemented to ensure raw materials, ingredients, packaging (including labels), work-in-progress, process inputs, and finished products are held under secure storage and transportation conditions; and

• The methods implemented to record and control access to the premises by site personnel, contractors, and visitors.

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:

• A risk analysis of those raw materials, ingredients, and processing aids, including food grade lubricants, that contain food allergens;

• An assessment of workplace-related food allergens that may originate from locker rooms, vending machines, lunchrooms, and visitors;

• A list of allergens that is applicable in the country of manufacture and the country(ies) of destination, if known;

• A list of allergens that is accessible to relevant staff;

• The control of hazards associated with allergens and incorporated into the food safety plan, and

• Management plans for control of the identified allergens.

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 are not possible.

2.9.2.1 A training program shall be documented and implemented that at a minimum outlines the necessary competencies for specific duties and the training methods to be applied to personnel carrying out tasks associated with:

• Implementing HACCP for staff involved in developing and maintaining food safety plans;

• Monitoring and corrective action procedures for all staff engaged in monitoring critical control points (CCPs);

• Personal hygiene for all staff involved in the handling of food products and food contact surfaces;

• Good Manufacturing Practices and work instructions for all staff engaged in food handling, food processing, and equipment;

• Sampling and test methods for all staff involved in sampling and testing of raw materials, packaging, work-in-progress, and finished products;

• Environmental monitoring for relevant staff;

• Allergen management, food defense, and food fraud for all relevant staff; and

• Tasks identified as critical to meeting the effective implementation and maintenance of the SQF code. The training program shall include provisions for identifying and implementing the refresher training needs of the organization.

2.9.2.3 Training records shall be maintained and include:

• Participant name;

• Skills description;

• Description of the training provided;

• Date training completed;

• Trainer or training provider; and

• Verification that the trainee is competent to complete the required tasks.