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SQF Checklist: Dietary Supplement Manufacturing - Edition 9

MaintainX
10/24/2021

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

    SQF System Elements for Food Manufacturing

    2.1 Management Commitment

    2.1.1 Management Responsibility (Mandatory)

    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:

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

    2.1.1.3

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

    2.1.1.5 The primary and substitute SQF practitioner shall:

    2.1.2 Management Review (Mandatory)

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

    2.1.3 Complaint Management (Mandatory)

    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:

    2.2 Document Control and Records

    2.2.1 Food Safety Management System (Mandatory)

    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:

    2.2.2 Document Control (Mandatory)

    2.2.3 Records (Mandatory)

    2.3 Specification, Formulations, Realization, and Supplier Approval

    2.3.1 Product Formulation and Realization

    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:

    2.3.2 Specifications (Raw Material, Packaging, Finished Product and Services)

    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:

    2.3.3 Contract Manufacturers

    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:

    2.3.4 Approved Supplier Program (Mandatory)

    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:

    2.4 Food Safety System

    2.4.1 Dietary Supplement Legislation (Mandatory)

    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:

    2.4.2 Good Manufacturing Practices (Mandatory)

    2.4.3 Food Safety Plan (Mandatory)

    2.4.4 Product Sampling, Inspection and Analysis

    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:

    2.4.4.2

    2.4.5 Non-conforming Materials and Product

    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:

    2.4.6 Product Rework

    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:

    2.4.7 Product Release (Mandatory)

    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:

    2.4.8 Environmental Monitoring

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

    2.5 SQF System Verification

    2.5.1 Validation and Effectiveness (Mandatory)

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

    2.5.2 Verification Activities (Mandatory)

    2.5.3 Corrective and Preventative Action (Mandatory)

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

    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:

    2.6 Product Traceability and Crisis Management

    2.6.1 Product Identification (Mandatory)

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

    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:

    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:

    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:

    2.6.4 Crisis Management Planning

    2.6.4.1 A crisis management plan based on the understanding of known potential dangers (e.g., flood, drought, fire, tsunami, or other severe weather events, warfare or civil unrest, computer outage, pandemic, loss of electricity or refrigeration, ammonia leak, labor strike) that can impact the site’s ability to deliver safe 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

    2.7 Food Defense and Food Fraud

    2.7.1 Food Defense Plan (Mandatory)

    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:

    2.7.2 Food Fraud (Mandatory)

    2.8 Allergen Management

    2.8.1 Allergen Management (Mandatory)

    2.8.1.1 The responsibility and methods used to control allergens and to prevent sources of allergens from contaminating product shall be documented and implemented. The allergen management program shall include:

    2.8.1.4

    2.9 Training

    2.9.1 Training Requirements

    2.9.2 Training Program (Mandatory)

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

    2.9.2.3 Training records shall be maintained and include:

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