Part II Appendices2.3.2All relevant information needed to conduct the hazard analysis shall be collected,
2.4 Identify intended use (equivalent to Codex Alimentarius Step 3) Clause Requirements
2.4.1 The intended use of the product by the customer, and expected alternative uses, shall be described, defining the consumer target groups, including the suitability of the product for vulnerable groups of the population (e.g. infants, elderly, allergy sufferers).
Interpretation Identify the use
The HACCP food safety team needs to consider and document the intended use of the products by the customer and the ultimate consumer to ensure all the risks have been assessed. For example, the team should consider:
• the target population (e.g. does this include high-risk groups such as infants, elderly people or allergy sufferers?)
• handling and preparation (e.g. will the product be consumed without further cooking?)
• the customer supply chain
• storage (e.g. frozen, or the requirement for chilled storage after opening the pack).
Where there is an expected alternative food use for a product, including the potential for a customer or consumer to misuse or mistreat the product in a way not intended by the manufacturer, this information should be included in the description in the HACCP assessment so that any implications can be considered as part of the subsequent hazard analysis. This alternative use may occur in the consumer’s home (e.g. consumption of a product that looks ready to eat without completing the correct cooking) or elsewhere in the supply chain (e.g. an unintended use of a raw material). A number of product recalls have occurred, for example, with frozen raw vegetables and coated/battered poultry products due to unintended use of the product. Inclusion of intended and expected alternative uses of a product can also provide a useful due diligence reference demonstrating to a customer or regulatory authority the scope of hazards that have been considered.
Part II Appendic es Clause Requirements
2.5.1 A flow diagram shall be prepared to cover each product, product category or process. This shall set out all aspects of the food process operation within the HACCP or food safety plan scope, from raw material receipt through to processing, storage and distribution. As a guide, this should include the following, although this is not an exhaustive list:
• plan of premises and equipment layout
• raw materials, including introduction of utilities and other contact materials (e.g. water, packaging)
• sequence and interaction of all process steps
• outsourced processes and subcontracted work
• potential for process delay
• rework and recycling
• low-risk/high-risk/high-care area segregation
• finished products, intermediate/semi-processed products, by-products and waste.
Interpretation Process flow diagram
The process flow diagram provides the site with an important tool, allowing it to evaluate the possible introduction, occurrence or change of hazards at each step of the process. It should therefore be used when identifying hazards (see clause 2.7.1) and conducting hazard analysis (see clause 2.7.2).
Therefore, an accurate flow diagram indicating all the process steps, including all inputs and outputs, needs to be constructed for each HACCP or food safety plan. This may be achieved with a single diagram, or it could be in a modular form with several documents compiled to provide the complete information (in this situation it must clearly identify the interaction between the process steps). The Standard lists guidance on the points to consider and include when developing the flow diagram; for example:
• a plan of the premises and equipment layout to facilitate consideration of cross- contamination risks (e.g. allergen control)
• raw materials – it should be clear where raw materials are stored and the routes they take into the production area; this includes the introduction of utilities and other contact materials (e.g. water or packaging)
• sequence and interaction of all process steps (e.g. method of transportation between each step)
• outsourced processes and subcontracted work, including, for example, off-site processing, storage, packing or transport
• potential for process delay (i.e. how products or ingredients will be handled if a delay occurs)
• rework and recycling
• low-risk/high-risk/high-care segregation (i.e. clearly indicating where the different production zones are located)
• finished products, intermediate/semi-processed products, by-products and waste (e.g.
where waste products leave the production process, and the storage of intermediates and finished products).
Clause 3.2.1 of the Standard requires the site to have an effective document control system.
Signing and dating the approved process flow diagram is one method of demonstrating that this is occurring.
Examples There is no set pattern or format for the diagram. However, it is important to show all the steps in the process, from raw materials through to final products, as shown in Figure 1.
Raw Materials
All Process Stages
Product
Figure 1 Example of a process flow diagram: linear
All products must be covered in the diagram, so if your site has a wide range of similar products or processes, a modular option may be preferable; Figures 2 and 3 show examples.
Otherwise a separate linear diagram is needed for each product; i.e. 20 products would need 20 linear process flow diagrams.
Raw Materials
All Process Stages
Product B
All Process Stages
Product C All Process Stages
Product A
Figure 2 Example of a modular process flow diagram (1)
Part II Appendic es
Examples continued
All Process Stages Steamed Ingredients
(See HACCP Study B1) Final Products
Deep Fat Frying (See HACCP Study A1)
Raw Ingredients
Figure 3 Example of a modular process flow diagram (2)
If you use a modular or generic diagram, take care to ensure that it includes all steps and all products. If your site manufactures multiple products that are considerably different or require different processes, you will need to have several separate diagrams.
In addition to the process steps, the diagram needs to contain:
• all raw materials used in the manufacture of the product(s), including the introduction of utilities and other contact materials (e.g. water or packaging)
• details of any outsourced or subcontracted process (i.e. any activity that is part of the production process but does not occur on site)
• rework or recycling
• low-risk, high-care and high-risk segregation
• routes taken by waste products
• all finished products, intermediates, semi-processed products or by-products.
Examples of completed process flow diagrams are shown in Figures 4 and 5.
Examples continued
8. Sieving (Xμm) 9. Tempering
(Ambient ≤X hours) 5. Bulk Storage (Ambient)
1. Flour 2. Sugar
7. Chilled Storage (X-YoC)
11. Weighing Up
12. Mixing
13. Forming
17. Baking (≥X C, Y minutes)
18. Cooling (Ambient, X minutes)
21. Packing
23. Date Coding
24. Metal Detection
25. Ambient Storage
16. Waste 15. Rework
6. Ambient Storage 3. Walnuts
10. Water
26. Dispatch
22. Waste 20. Packaging Store
19. Pre-Printed Plastic Wrap
Figure 4 Example of a completed process flow diagram: walnut biscuit
Part II Appendic es
Examples continued
7. Curing Brine Preparation
6. Water 8. Injection 9. Thaw (X C for Y-Z hours)
4. Ambient Storage
1. Salt (NaCl) 2. Nitrite Curing Salt
5. Frozen Storage (<XoC) 3. Trimmed Pork Joints
10. Tumbling 11. Waste (Brine)
12. Cooking (≥XoC for Y minutes)
13. Cooling Blast Chill (<XoC within Y hours)
14. Chilled Storage (X-Yo (if required due to delay
)
20. Packing & Labelling
21. Date Coding
22. Metal Detection
23. Chilled Storage (X-YoC)
24. Chilled Dispatch (X-Y C)
16. Waste
19. Disinfection 18. Packaging Store
17. Plastic Trays, Film Lids & Labels
LOW RISK HIGH RISK
HIGH RISK ENCLOSED PRODUCT AREA
Figure 5 Example of a completed process flow diagram: cooked cured meat