ISO 22000 - (Section 7 - Planning and realization of safe products)

7.3. Preliminary steps to enable hazard analysis

7.3.1 General

All relevant information needed to conduct the hazard analysis shall be collected, maintained, updated and documented. Records shall be maintained.


7.3.2 Food safety team

A food safety team shall be appointed.


The food safety team shall have a combination of multi-disciplinary knowledge and experience in developing and implementing the food safety management system. This includes, but need not be limited to, the organization's products, processes, equipment and food safety hazards within the scope of the food safety management system.


Records shall be maintained that demonstrate that the food safety team has the required knowledge and experience (see 6.2.2).


7.3.3 Product characteristics


7.3.3.1 Raw materials, ingredients and product-contact materials

All raw materials, ingredients and product-contact materials shall be described in documents to the extent needed to conduct the hazard analysis (see 7.4), including the following, as appropriate:

  1. biological, chemical and physical characteristics;
  2. composition of formulated ingredients, including additives and processing aids;
  3. origin;
  4. method of production;
  5. packaging and delivery methods;
  6. storage conditions and shelf life;
  7. preparation and/or handling before use or processing;
  8. food safety-related acceptance criteria or specifications of purchased materials and ingredients appropriate to their intended uses.

The organization shall identify statutory and regulatory food safety requirements related to the above.


The descriptions shall be kept up-to-date including, when required, in accordance with 7.7.


7.3.3.2 Characteristics of end products

The characteristics of end products shall be described in documents to the extent needed to conduct the hazard analysis (see 7.4), including information on the following, as appropriate:

  1. product name or similar identification;
  2. composition;
  3. biological, chemical and physical characteristics relevant for food safety;
  4. intended shelf life and storage conditions;
  5. packaging;
  6. labelling relating to food safety and/or instructions for handling, preparation and usage;
  7. method(s) of distribution.

The organization shall identify statutory and regulatory food safety requirements related to the above.


The descriptions shall be kept up-to-date including, when required, in accordance with 7.7.


7.3.4 Intended use

The intended use, the reasonably expected handling of the end product, and any unintended but reasonably expected mishandling and misuse of the end product shall be considered and shall be described in documents to the extent needed to conduct the hazard analysis (see 7.4).

Groups of users and, where appropriate, groups of consumers shall be identified for each product, and consumer groups known to be especially vulnerable to specific food safety hazards shall be considered. The descriptions shall be kept up-to-date including, when required, in accordance with 7.7.


7.3.5 Flow diagrams, process steps and control measures


7.3.5.1 Flow diagrams

Flow diagrams shall be prepared for the products or process categories covered by the food safety management system. Flow diagrams shall provide a basis for evaluating the possible occurrence, increase or introduction of food safety hazards.

Flow diagrams shall be clear, accurate and sufficiently detailed. Flow diagrams shall, as appropriate, include the following:

  1. the sequence and interaction of all steps in the operation;
  2. any outsourced processes and subcontracted work;
  3. where raw materials, ingredients and intermediate products enter the flow;
  4. where reworking and recycling take place;
  5. where end products, intermediate products, by-products and waste are released or removed.

In accordance with 7.8, the food safety team shall verify the accuracy of the flow diagrams by on-site checking. Verified flow diagrams shall be maintained as records.


7.3.5.2 Description of process steps and control measures

The existing control measures, process parameters and/or the rigorousness with which they are applied, or procedures that may influence food safety, shall be described to the extent needed to conduct the hazard analysis (see 7.4).


External requirements (e.g. from regulatory authorities or customers) that may impact the choice and the rigorousness of the control measures shall also be described.


The descriptions shall be updated in accordance with 7.7.