Self-Evaluation/Audit Checklist for Food Supplement Manufacturers

Is there a self-audit system in place to guarantee food safety based on the HACCP principles?

• Yes
• No
• N / A

Are the elements of the company's food safety management system supported by documents?

• Yes
• No
• N / A

Have the elements of the company's food safety management system been implemented?

• Yes
• No
• N / A

Are the elements of the company's food safety management system applied at all times?

• Yes
• No
• N / A

Are the elements of the company's food safety management system reviewed regularly?

• Yes
• No
• N / A

Does the company have a clear, succinct and documented food safety policy?

• Yes
• No
• N / A

Does the company have a food safety manual (quality manual)?

• Yes
• No
• N / A

Is there a company organisation chart (roles, qualifications, deputies)?

• Yes
• No
• N / A

Have tasks/responsibilities/competences been established?

• Yes
• No
• N / A

Does the management team work to develop and improve the management system with regard to food safety (date of last update)?

• Yes
• No
• N / A

Is the food safety management system regularly reviewed by senior management?

• Yes
• No
• N / A

Are all of the necessary material and human resources and information provided by senior management?

• Yes
• No
• N / A

Are all of these material and human resources and this information provided in good time by senior management?

• Yes
• No
• N / A

Is the system put in place for document management satisfactory?

• Yes
• No
• N / A

Have specifications been drawn up for finished products?

• Yes
• No
• N / A

Are all of the procedures necessary for demonstrating compliance with legislation in place?

• Yes
• No
• N / A

Are all of the procedures necessary for demonstrating product safety compliance in place?

• Yes
• No
• N / A

Is the procedure for carrying out internal audits satisfactory?

• Yes
• No
• N / A

Is the procedure in place for implementing corrective measures satisfactory?

• Yes
• No
• N / A

Does the company ensure that any products that do not meet requirements are clearly identified and checked to prevent accidental use or delivery?

• Yes
• No
• N / A

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?

• Yes
• No
• N / A

Does the goods-in inspection procedure guarantee that purchased products comply with specifications?

• Yes
• No
• N / A

Is there a list of suppliers?

• Yes
• No
• N / A

Is the supplier evaluation procedure satisfactory (criteria, warnings, recall measures)?

• Yes
• No
• N / A

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)?

• Yes
• No
• N / A

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)?

• Yes
• No
• N / A

Does the operator have systems or procedures for establishing relationships between incoming and outgoing products?

• Yes
• No
• N / A

Are products that have been reworked identified again?

• Yes
• No
• N / A

Is the complaints management system satisfactory?

• Yes
• No
• N / A

Does the company have a system for recalls and returns?

• Yes
• No
• N / A

Does the company have a system for handling recalled products and returns?

• Yes
• No
• N / A

Does the company have procedures in place for calibrating equipment used for measurements relating to food safety?

• Yes
• No
• N / A

Does the company have a system for taking the samples required by law?

• Yes
• No
• N / A

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?

• Yes
• No
• N / A

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?

• Yes
• No
• N / A

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 foo food supplements have been carried out?

• Yes
• No
• N / A

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?

• Yes
• No
• N / A

Can the authorisation(s) provided for by the law be for the manufacturing of food supplements at your premise(s) be produced?

• Yes
• No
• N / A

Are all the manufacturing activities carried out at your premises covered by the authorisation(s) you have received from the relevant national authorities?

• Yes
• No
• N / A

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?

• Yes
• No
• N / A

Do the goods have the required labels?

• Yes
• No
• N / A

Do the labels include the required information?

• Yes
• No
• N / A

Is the company situated in a clean environment to prevent any contamination and enable safe products to be produced?

• Yes
• No
• N / A

Are the undeveloped areas of the site on which the company's buildings are constructed well maintained?

• Yes
• No
• N / A

Is the layout designed in such a way as to manage the risk of product crosscontamination?

• Yes
• No
• N / A

Are the premises organised in such a way that is suitable for their intended use?

• Yes
• No
• N / A

Is the type of equipment used suitable for ensuring the safety of the products?

• Yes
• No
• N / A

Is the equipment installed in such a way that cleaning and disinfection work can be done all around the equipment?

• Yes
• No
• N / A

Is there a maintenance system in place for all of the equipment components that may affect the safety of the products?

• Yes
• No
• N / A

Does the layout of social areas guarantee the safety of the products?

• Yes
• No
• N / A

Are the necessary procedures in place to manage the risks of physical, chemical or (micro) biological product contamination?

• Yes
• No
• N / A

Are temperature requirements met at all times?

• Yes
• No
• N / A

Are the necessary procedures in place for managing the risk of cross-contamination?

• Yes
• No
• N / A

Are the necessary procedures in place to ensure that the oldest raw materials, packaging materials and finished products or those nearing their expiry date are used first?

• Yes
• No
• N / A

Are the necessary procedures in place to ensure that raw materials, packaging materials and finished products are used in accordance with their use-by dates?

• Yes
• No
• N / A

Are appropriate rules regarding upkeep followed at all times?

• Yes
• No
• N / A

Are appropriate rules regarding cleaning followed at all times?

• Yes
• No
• N / A

Are appropriate rules regarding hygiene followed at all times?

• Yes
• No
• N / A

Does the company carry out visual cleaning and disinfection inspections?

• Yes
• No
• N / A

Is the quality of water that comes into contact with food regularly checked and is it of "drinking water" quality?

• Yes
• No
• N / A

Are there adequate systems in place for collecting, storing and disposing of waste?

• Yes
• No
• N / A

Is waste management within the company satisfactory?

• Yes
• No
• N / A

Does the company have a system in place for managing or preventing pests on the site or in the establishment?

• Yes
• No
• N / A

Is waste management within the company satisfactory?

• Yes
• No
• N / A

Are general transport requirements met?

• Yes
• No
• N / A

Are all of the vehicles used to transport raw materials (including packaging material), semi-finished products and finished products fit for purpose?

• Yes
• No
• N / A

Are all of the vehicles used to transport raw materials (including packaging material), semi-finished products and finished products properly maintained?

• Yes
• No
• N / A

Are all of the vehicles used to transport raw materials (including packaging material), semi-finished products and finished products cleaned in accordance with legal requirements?

• Yes
• No
• N / A

Are specific requirements regarding tanker transport met?

• Yes
• No
• N / A

Does the company have documented rules relating to hygiene and management of product contamination risks and are personnel familiar with these rules?

• Yes
• No
• N / A

Does the company have a system for ensuring that all workers are properly trained, receive correct instructions and are subject to surveillance with regard to food safety?

• Yes
• No
• N / A

Does the company comply with legislation that has to be checked on behalf of third parties?

• Yes
• No
• N / A

Is there sufficient knowledge and experience specific to the products to be able to draw up an effective HACCP plan?

• Yes
• No
• N / A

Has the scope of the HACCP plan been described?

• Yes
• No
• N / A

Does this description indicate which segments of the food production industry are affected?

• Yes
• No
• N / A

Does it indicate to which general risk categories attention needs to be paid?

• Yes
• No
• N / A

Has a full description of the product been produced, including in particular the relevant safety information?

• Yes
• No
• N / A

Does the intended use take into account how the end user or consumer can normally be expected to use the product?

• Yes
• No
• N / A

Have all of the stages been included in the diagram?

• Yes
• No
• N / A

At each stage of the process, are the relationships between the previous and following stages taken into account?

• Yes
• No
• N / A

Has the HACCP team compared the manufacturing process with the diagram at every stage?

• Yes
• No
• N / A

Has the diagram been adapted where necessary?

• Yes
• No
• N / A

Has the HACCP team drawn up a list of all of the hazards it feels may reasonably occur at each stage?

• Yes
• No
• N / A

Has a note been made of those hazards identified that must be prevented, removed or reduced to an acceptable level to produce safe foodstuffs?

• Yes
• No
• N / A

Has it been indicated at which stages of the process these hazards must be prevented, removed or reduced to an acceptable level?

• Yes
• No
• N / A

Have these limits been approved?

• Yes
• No
• N / A

For each CCP, is there a programmed monitoring system in place concerning the critical limits so that it is immediately clear if a CCP is not being controlled?

• Yes
• No
• N / A

Can the system correct the loss of control before it exceeds the limits set?

• Yes
• No
• N / A

Have corrective measures specific to each CCP been established in the HACCP system to ensure that any deviations beyond the limits can be put right?

• Yes
• No
• N / A

Have procedures been put in place to check the system?

• Yes
• No
• N / A

Are the HACCP procedures supported by documents and records?

• Yes
• No
• N / A

Are these documents and records appropriate to the nature and the scope of the process?

• Yes
• No
• N / A

Have sampling and analysis plans been established (where necessary) to ensure the validity of the self-audit system?

• Yes
• No
• N / A