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Self-Evaluation/Audit Checklist for Food Supplement Manufacturers

MaintainX
10/24/2021

Self-Evaluation/Audit Checklist for Food Supplement Manufacturers

    Food Safety Management System

    General Requirements

  • 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
  • Food Safety Policy

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

    • Yes
    • No
    • N / A
  • Food Safety Manual

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

    • Yes
    • No
    • N / A
  • Responsibility of company management (operator)

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

    • Yes
    • No
    • N / A
  • Have tasks/responsibilities/competences been established?

    • Yes
    • No
    • N / A
  • Commitment of company management (operator)

  • 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
  • Review by company management (including HACCP plan)

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

    • Yes
    • No
    • N / A
  • Management of material/human resources and information

  • 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
  • General requirements regarding documentation

  • Is the system put in place for document management satisfactory?

    • Yes
    • No
    • N / A
  • Specifications

  • Have specifications been drawn up for finished products?

    • Yes
    • No
    • N / A
  • Procedures

  • 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
  • Internal audit and internal control

  • Is the procedure for carrying out internal audits satisfactory?

    • Yes
    • No
    • N / A
  • Corrective action

  • Is the procedure in place for implementing corrective measures satisfactory?

    • Yes
    • No
    • N / A
  • Checking of nonconformities

  • 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
  • Product Release

  • 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
  • Purchasing

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

    • Yes
    • No
    • N / A
  • Monitoring of supplier services

  • Is there a list of suppliers?

    • Yes
    • No
    • N / A
  • Is the supplier evaluation procedure satisfactory (criteria, warnings, recall measures)?

    • Yes
    • No
    • N / A
  • Traceability

  • 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
  • Complaint Handling

  • Is the complaints management system satisfactory?

    • Yes
    • No
    • N / A
  • Product Recall & Returns

  • 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
  • Inspection of measuring and monitoring equipment

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

    • Yes
    • No
    • N / A
  • Product Analysis

  • 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
  • Mandatory Notification(s)

  • 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
  • Approvals (Where Relevant)

  • 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
  • Labelling

  • Do the goods have the required labels?

    • Yes
    • No
    • N / A
  • Do the labels include the required information?

    • Yes
    • No
    • N / A
  • Good Manufacturing & Distribution Practices Good Manufacturing & Distribution Practices

  • Company Environment

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

    • Yes
    • No
    • N / A
  • Environment of buildings

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

    • Yes
    • No
    • N / A
  • Layout and product flow

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

    • Yes
    • No
    • N / A
  • Layout of premises (handling of raw materials, manufacture, processing, packing, packaging and warehouses)

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

    • Yes
    • No
    • N / A
  • Equipment

  • 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
  • Maintenance

  • 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
  • Social Areas

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

    • Yes
    • No
    • N / A
  • Risk of physical, chemical and (micro)biological contamination of the product

  • 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
  • Separation and cross-contamination

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

    • Yes
    • No
    • N / A
  • Stock Management (rotation)

  • 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
  • Housekeeping, cleaning and hygiene

  • 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
  • Water Quality Management

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

    • Yes
    • No
    • N / A
  • Waste Management

  • 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
  • Pest Control

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

    • Yes
    • No
    • N / A
  • Use of pesticides, herbicides and fungicides

  • Is waste management within the company satisfactory?

    • Yes
    • No
    • N / A
  • Transport

  • 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
  • Personal hygiene, protective clothing and medical examination

  • 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
  • Training

  • 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
  • Checks on behalf of Third Parties

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

    • Yes
    • No
    • N / A
  • Hazard Analysis & Critical Control Points (HACCP)

  • Composition of the HACCP team

  • 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
  • Product Description

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

    • Yes
    • No
    • N / A
  • Identification of Intended Use

  • 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
  • Establishment of a production process diagram

  • 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
  • On-site confirmation of the diagram

  • 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
  • Establishment of a list of all of the possible hazards at each stage, performance of a risk analysis and consideration of measures designed to manage the hazards identified (HACCP principle 1)

  • 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
  • Identification of critical control points (HACCP principle 2)

  • 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
  • Setting of critical limits (HACCP principle 3)

  • Have these limits been approved?

    • Yes
    • No
    • N / A
  • Creation of a monitoring system for each CCP (HACCP principle 4)

  • 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
  • Corrective measures (HACCP principle 5)

  • 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
  • Verification procedures (HACCP principle 6)

  • Have procedures been put in place to check the system?

    • Yes
    • No
    • N / A
  • Compilation of documentation and record keeping (HACCP principle 7)

  • 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
  • Sampling and analysis plans

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

    • Yes
    • No
    • N / A

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