Title Page
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Client / Site
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Conducted on (Date and Time)
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Inspected by
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Location
General Requirements
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Is there a self-audit system in place to guarantee food safety based on the HACCP principles?
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Are the elements of the company's food safety management system supported by documents?
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Have the elements of the company's food safety management system been implemented?
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Are the elements of the company's food safety management system applied at all times?
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Are the elements of the company's food safety management system reviewed regularly?
Food Safety Policy
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Does the company have a clear, succinct and documented food safety policy?
Food Safety Manual
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Does the company have a food safety manual (quality manual)?
Responsibility of company management (operator)
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Is there a company organization chart (roles, qualifications, deputies)?
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Have tasks/responsibilities/competences been established?
Commitment of company management (operator)
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Does the management team work to develop and improve the management system with regard to food safety (date of the last update)?
Review by company management (including HACCP plan)
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Is the food safety management system regularly reviewed by senior management?
Management of material/human resources and information
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Are all of the necessary material and human resources and information provided by senior management?
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Are all of these material and human resources and this information provided in good time by senior management?
General requirements regarding documentation
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Is the system put in place for document management satisfactory?
Specifications
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Have specifications been drawn up for finished products?
Procedures
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Are all of the procedures necessary for demonstrating compliance with legislation in place?
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Are all of the procedures necessary for demonstrating product safety compliance in place?
Internal audit and control
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Is the procedure for carrying out internal audits satisfactory?
Corrective action
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Is the procedure in place for implementing corrective measures satisfactory?
Checking of nonconformities
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Does the company ensure that any products that do not meet requirements are clearly identified and checked to prevent the accidental use or delivery?
Product Release
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Does the company have a product release procedure in place that ensures that the product is not released unless all of the specific requirements have been met?
Purchasing
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Does the goods-in inspection procedure guarantee that purchased products comply with specifications?
Monitoring of supplier services
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Is there a list of suppliers?
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Is the supplier evaluation procedure satisfactory (criteria, warnings, recall measures)?
Traceability
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Does the operator have systems or procedures for recording incoming products (type, identification, and quantity of product, date of receipt and identification of the originating establishment)?
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Does the operator have systems or procedures for recording outgoing products (type, identification, and quantity of product, delivery date and identification of the destination establishment)?
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Does the operator have systems or procedures for establishing relationships between incoming and outgoing products?
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Are products that have been reworked identified again?
Complaint Handling
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Is the complaints management system satisfactory?
Product Recall & Returns
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Does the company have a system for recalls and returns?
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Does the company have a system for handling recalled products and returns?
Inspection of measuring and monitoring equipment
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Does the company have procedures in place for calibrating equipment used for measurements relating to food safety?
Product Analysis
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Does the company have a system for taking the samples required by law?
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Does the company have an appropriate procedure in place for performing or outsourcing the relevant raw material analyses in preparation for confirming the safety of the product?
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Does the company have an appropriate procedure in place for performing or outsourcing the relevant finished product analyses in preparation for confirming the safety of the product?
Mandatory Notification(s)
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Can you provide proof that the mandatory notifications to the relevant authorities when placing food supplement products on the market in accordance with Directive 2002/46/EC on food supplements have been carried out?
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Does your company have systems in place to ensure that the relevant authorities are notified immediately as required by law in the event of non-conformities being discovered for products that have been placed on the market?
Approvals (Where Relevant)
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Can the authorization(s) provided for by the law be for the manufacturing of food supplements at your premise(s) be produced?
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Are all the manufacturing activities carried out at your premises covered by the authorization(s) you have received from the relevant national authorities?
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If your country applies an approval system for the placing of food supplement products on the market, can you provide the relevant approval certifications for all products?
Labelling
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Do the goods have the required labels?
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Do the labels include the required information?
Completion
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Recommendations
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Inspector's Full Name and Signature