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.
2.2 Prerequisite programmers
2.2.1 The site shall establish and maintain environmental and operational programmes necessary to create an environment suitable to produce safe and legal food products (prerequisite programmes). As a guide these may include the following, although this
cleaning and sanitizing
maintenance programmers for equipment and buildings
personal hygiene requirements
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
2.3 Describe the product (equivalent to Codex Alimentary Step 2)
2.3.1 A full description for each product or group of products shall be developed, which includes all relevant information on food safety. As a guide, this may include the following, although this is not an exhaustive list:
composition (e.g. raw materials, ingredients, allergens, recipe)
origin of ingredients
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.
2.3.2 All relevant information needed to conduct the hazard analysis shall be collected, maintained, documented and updated. The company will ensure that the HACCP or food safety plan is based on comprehensive information sources, which are referenced an
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 Identify intended use (equivalent to Codex Alimentarius Step 3)
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
2.5 Construct a process flow diagram (equivalent to Codex Alimentary Step 4)
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
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/semiprocessed products, by-products and waste.
2.6 Verify flow diagram (equivalent to Codex Alimentarius Step 5)
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.
2.7 List all potential hazards associated with each process step, conduct a hazard analysis and consider any measures to control identified hazards (equivalent to Codex Alimentarius Step 6, Principle 1)
2.7.1 The HACCP food safety team shall identify and record all the potential hazards that are reasonably expected to occur at each step in relation to product, process and facilities.
This shall include hazards present in raw materials, those introduced during the process or surviving the process steps, and consideration of the following types of hazard:
chemical and radio logical contamination
fraud (e.g. substitution or deliberate/intentional adulteration)
malicious contamination of products
allergen risks (see clause 5.3)
It shall also take account of the preceding and following steps in the process chain.
2.7.2 The HACCP food safety team shall conduct a hazard analysis to identify hazards which need to be prevented, eliminated or reduced to acceptable levels. Consideration shall be given to the following:
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.
Where elimination of the hazard is not practical, justification for acceptable levels of the hazard in the finished product shall be determined and documented.
2.7.3 The HACCP food safety team shall consider the control measures necessary to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Where the control is achieved through existing prerequisite programmers,
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.
2.8 Determine the critical control points (CCPs) (equivalent to Codex Alimentary Step 7, Principle 2)
2.8.1 For each hazard that requires control, control points shall be reviewed to identify those that are critical. This requires a logical approach and may be facilitated by use of a decision tree. Critical control points (CCPs) shall be those control poi
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.
2.9 Establish critical limits for each CCP (equivalent to Codes Alimentary Step 8, Principle 3)
2.9.1 For each CCP, the appropriate critical limits shall be defined in order to identify clearly whether the process is in or out of control. Critical limits shall be:
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.
2.10 Establish a monitoring system for each CCP (equivalent to Codex Alimentary Step 9, Principle 4)
2.10.1 A monitoring procedure shall be established for each CCP to ensure compliance with critical limits. The monitoring system shall be able to detect loss of control of CCPs and, wherever possible, provide information in time for corrective action to
As a guide, consideration may be given to the following, although this is not an exhaustive list:
continuous measurement (e.g. thermographs, pH meters etc.)
Where discontinuous measurement is used, the system shall ensure that the sample taken is representative of the batch of product.
2.10.2 Records associated with the monitoring of each CCP shall include the date, time and result of measurement and shall be signed by the person responsible for the monitoring and verified, when appropriate, by an authorised person.
Where records are in electronic form, there shall be evidence that records have been checked and verified.
2.11 Establish a corrective action plan (equivalent to Codex Alimentary Step 10, Principle 5)
2.11.1 The HACCP food safety team shall specify and document the corrective action to be taken when monitored results indicate a failure to meet a control limit, or when monitored results indicate a trend towards loss of control.
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.
2.12 Establish verification procedures (equivalent to Codex Alimentarius Step 11, Principle 6)
2.12.1 Procedures of verification shall be established to confirm that the HACCP or food safety plan, including controls managed by prerequisite programmes, continues to be effective. Examples of verification activities include:
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.
Results of verification shall be recorded and communicated to the HACCP food safety team.
2.13 HACCP documentation and record-keeping (equivalent to Codex Alimentarius Step 12, Principle 7)
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.
2.14 Review the HACCP plan
2.14.1 The HACCP food safety team shall review the HACCP or food safety plan and prerequisite programmes at least annually and prior to any changes which may affect food safety.
As a guide, these may include the following, although this is not an exhaustive list:
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.
Appropriate changes resulting from the review shall be incorporated into the HACCP or food safety plan and/or prerequisite programmes, fully documented and the validation recorded.
Where appropriate, the changes shall also be reflected in the company’s product safety policy and food safety objectives.