2.1.1 The HACCP or food safety plan shall be developed and managed by a multidisciplinary food safety team that includes those responsible for quality assurance, technical management, production operations, engineering and other relevant functions.
The team members shall have specific knowledge of HACCP and relevant knowledge of products, processes and associated hazards.
The team leader shall have an in depth knowledge of Codex HACCP principles (or equivalent) and be able to demonstrate competence, experience and training. Where there is a legal requirement for specific training, this shall be in place.
In the event of the site not having the appropriate in-house knowledge, external expertise may be used, but day-to-day management of the food safety system shall remain the responsibility of the company.
maintenance programmers for equipment and buildings
personal hygiene requirements
transportation arrangements
processes to prevent cross contamination
The control measures and monitoring procedures for the prerequisite programmes must be clearly documented and shall be included within the development and reviews of the HACCP or food safety plan. The control measures and monitoring procedures for the pre
composition (e.g. raw materials, ingredients, allergens, recipe)
physical or chemical properties that impact food safety (e.g. pH, aw)
treatment and processing (e.g. cooking, cooling)
packaging system (e.g. modified atmosphere, vacuum)
storage and distribution conditions (e.g. chilled, ambient)
maximum safe shelf life under prescribed storage and usage conditions.
the latest scientific literature
historical and known hazards associated with specific food products
relevant codes of practice
food safety legislation relevant for the production and sale of products
2.4.1 The intended use of the product by the customer, and any known alternative use, 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
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
low-risk/high-risk/high-care area segregation
2.6.1 The HACCP food safety team shall verify the accuracy of the flow diagrams by on-site audit and challenge at least annually. Daily and seasonal variations shall be considered and evaluated. Records of verified flow diagrams shall be maintained.
chemical and radio logical contamination
fraud (e.g. substitution or deliberate/intentional adulteration)
malicious contamination of products
allergen risks (see clause 5.3)
likely occurrence of hazard
severity of the effects on consumer safety
vulnerability of those exposed
survival and multiplication of micro-organisms of specific concern to the product
presence or production of toxins, chemicals or foreign bodies
contamination of raw materials, intermediate/semi-processed product, or finished product.
this shall be stated and the adequacy of the programme to control the specific hazard validated. Consideration may be given to using more than one control measure.
If a hazard is identified at a step where control is necessary for safety but the control does not exist, the product or process shall be modified at that step, or at an earlier step, to provide a control measure.
measurable wherever possible (e.g. time, temperature, pH)
supported by clear guidance or examples where measures are subjective (e.g. photographs).
2.9.2 The HACCP food safety team shall validate each CCP. Documented evidence shall show that the control measures selected and critical limits identified are capable of consistently controlling the hazard to the specified acceptable level.
continuous measurement (e.g. thermographs, pH meters etc.)
Where records are in electronic form, there shall be evidence that records have been checked and verified.
This shall include the action to be taken by nominated personnel with regard to any products that have been manufactured during the period when the process was out of control.
review of records where acceptable limits have been exceeded
review of complaints by enforcement authorities or customers
review of incidents of product withdrawal or recall.
2.13.1 Documentation and record-keeping shall be sufficient to enable the site to verify that the HACCP and food safety controls, including controls managed by prerequisite programmers, are in place and maintained.
change in raw materials or supplier of raw materials
change in ingredients/recipe
change in processing conditions, process flow or equipment
change in packaging, storage or distribution conditions
change in packaging, storage or distribution conditions
emergence of a new risk (e.g. known adulteration of an ingredient or other relevant, published information, such as the recall of a similar product)
review following a recall
new developments in scientific information associated with ingredients, process or product.