Part II Appendic es
Interpretation The HACCP food safety team (aligned with Codex Alimentarius Step 1)
For a comprehensive HACCP or food safety plan to be established, maintained and kept up to date it needs to be managed by a nominated team with suitable training, relevant skills and experience.
The number of HACCP food safety team members needs to be appropriate to the size and structure of the company, as the team will include representatives of each department with responsibility for the operation of the Standard (e.g. technical, quality assurance, purchasing, engineering, new product development, hygiene/sanitation and senior leadership team).
There will always be more than one person, since a single person does not constitute a
‘team’. The team needs knowledge of the types of operations that are carried out at the site and the hazards these operations may present to the product.
It is good practice to document the team members within the study, with a summary of their roles, experience and areas of responsibility within the company. Membership of the HACCP food safety team needs to be reviewed and, when necessary, updated (e.g. when job responsibilities change or personnel leave or join the company).
The team leader must be able to demonstrate competency and experience in HACCP/food safety processes. This can be shown by:
• the quality of the plan
• documented evidence of their qualification (e.g. successful completion of an industry- recognised HACCP training course)
• demonstrable, extensive experience in implementing or training HACCP.
The team will need sufficient knowledge of HACCP processes, products manufactured on site, production processes and relevant hazards, to facilitate a thorough hazard and risk analysis and the creation of an appropriate food safety plan. This may be demonstrated by, for example, training records (see clause 7.1.6) that show adequate training (e.g. through an industry-recognised training course or good quality internal training) has been given to all HACCP food safety team members. Any format or delivery method of training is permitted;
however, the outcome should be a suitably trained individual capable of executing a HACCP or food safety plan as part of their team.
Where there is a legal requirement for specific training the site is expected to ensure this has been completed.
Where external expertise has been used in developing the HACCP or food safety plan, the site must demonstrate ownership of the identified requirements by ensuring that the day- to-day management of the food safety system remains the responsibility of the site (see clause 1.2.4).
At the audit, the competency and understanding of the HACCP/food safety plan team will be assessed, as well as the quality of the resultant HACCP or food safety plan. The site should also be able to establish the training and competence of any external consultant in HACCP/food safety principles (see section 3.5.3).
Senior management commitment (clauses 1.1.1 to 1.1.14) is required to support the HACCP food safety team. This may be demonstrated by the presence of senior management within the team, policy statements referring to HACCP or food safety, or evidence within management review meetings that HACCP/food safety issues are discussed and reviewed.
Interpretation
continued The existence of a food safety plan does not, in itself, guarantee product safety, and it is vital that the results of the HACCP or food safety plan are implemented, applied correctly and integrated into the food safety and quality management system.
2.1.2 The scope of each HACCP or food safety plan, including the products and processes covered, shall be defined.
Interpretation Scope of the HACCP or food safety plan
The scope of the HACCP or food safety plan must be identified. The scope should describe all the products and processes to be included within the study. In sites with a small range of similar products, it may be possible to incorporate all of the products and processes into a single HACCP or food safety plan; however, where there is a wide range of different products or processes with different hazards, it is likely that the site will need to use more than one plan.
The format of these plans is not prescribed by the Standard; various formats are acceptable as long as the scope for each plan is clearly defined and all activities and products are covered within the processes. For example, a HACCP or food safety plan may cover each group of products with similar process characteristics, or the plan may be split into ‘modules’
which cover specific process steps; these modules can then be used in a ‘mix and match’
structure to create a HACCP or food safety plan for any given product.
2.2 Prerequisite programmes Clause Requirements
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 is not an exhaustive list:
• cleaning and disinfection (see section 4.11)
• pest management (see section 4.14)
• maintenance programmes for equipment and buildings (see sections 4.4 and 4.6)
• personal hygiene requirements (see section 7.2)
• staff training (see section 7.1)
• supplier approval and purchasing (see section 3.5.1)
• transportation arrangements (see section 4.16)
• processes to prevent cross-contamination (see sections 4.9 and 4.10)
• allergen management (see section 5.3).
The prerequisite programmes for the particular areas of the site shall take into account the production risk zoning (see clause 4.3.1).
The control measures and monitoring procedures for the prerequisite programmes shall be clearly documented and shall be included within the development and reviews of the HACCP or food safety plan.
Part II Appendic es
Interpretation Prerequisites
The prerequisites are the basic environmental and production conditions necessary for the manufacture of safe food and the control of generic hazards. Note that the list of examples in the Standard is not exhaustive, and others will exist in some sites; for example, utilities, air and general aspects of the production environment. Sites must therefore define the full range of prerequisites applicable to their site and operations.
Although the prerequisites are usually covered by day-to-day activities such as good manufacturing or hygiene practices, it is vital that they work effectively and to the correct standards as:
• The prerequisite programme needs to provide a solid base on which the rest of the HACCP or food safety plan can be developed.
• The company is relying on the prerequisite activities to mitigate the identified hazards and deliver safe product (e.g. if a site identifies cleaning as a prerequisite, then it relies on the cleaning activities to adequately remove food residues and dirt that might otherwise result in hazards such as allergen cross-contamination or microbiological contamination).
Therefore there should be a whole work stream behind each identified prerequisite to ensure that the relevant activity, procedures and policies are in place, that they are working correctly and that they continue to deliver the level of control required.
Although the prerequisite programme is expected to be effective in achieving the level of control required to ensure food safety, it is not a requirement that a documented validation of every prerequisite is undertaken, as prerequisite programmes typically cover a wide range of general environmental controls, often with results that are not quantifiable. However, where a prerequisite programme is used to manage a specific hazard (e.g. cleaning regimes used to prevent allergen cross-contamination), there needs to be a documented validation that the prerequisite controls the identified hazard (see clause 2.7.4 for further details regarding the validation). Some companies prefer to differentiate prerequisites that manage specific hazards from other prerequisites by referring to them as operational prerequisites (oPRPs).
Sites that need to meet the requirements of the US Food Safety Modernization Act (FSMA) should note that they must ensure that preventive controls are subject to validation and verification. Some of these controls may cover activities that have traditionally formed part of the prerequisite programme.
The clause contains references to later sections of the Standard which provide detail on the requirements for effective management of some specific prerequisites, including cleaning (section 4.11), pest management (section 4.14) and training (section 7.1). These are not intended to be an exhaustive list of all prerequisites or all the relevant sections of the Standard.
The prerequisite programmes are often dependent on the production risk zoning (see clause 4.3.1); for example, cleaning within a high-risk zone. Therefore it may be necessary to place greater attention on some prerequisites that are particularly important for food safety in those specific zones.
Good practice is to review the prerequisite programmes and their management. The frequency of this review should be based on risk, but it could be included, for example, in the annual review of the HACCP or food safety plan.
Clause Requirements
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.
Interpretation Product description
A full description of the product is required to ensure that all aspects that could potentially affect food safety are considered. The Standard gives guidance on the factors that may be considered:
• composition (e.g. raw materials or ingredients used, allergens, recipes)
• origin of the ingredients (e.g. climatic conditions, culture or food safety standards may make some countries a greater risk than others)
• physical or chemical properties that impact food safety (e.g. pH, aw)
• treatment and processing conditions (e.g. cooking, chilling)
• product packaging system (e.g. modified atmosphere, vacuum packing or canning)
• storage and distribution conditions (e.g. chilled, frozen or ambient)
• maximum safe shelf life under prescribed storage and usage conditions.
Good practice is not to simply describe the product, but to consider the possible implications of what will be needed later in the HACCP study. For example, when considering the origin of ingredients, rather than just stating the material comes from a specific country or region, it may be useful to consider whether the potential climatic conditions, culture or food safety standards in the country change the hazards.
Product groups can be used where the products are similar (e.g. different pack sizes).
However, where significantly different products (e.g. coated and non-coated meat products) are manufactured, these are to be treated as separate products or groups.