Qualifica tion
PLANNING AND REALIZATION OF SAFE PRODUCT
7.3 PRELIMINARY STEPS TO ENABLE HAZARD ANALYSIS .1 General
7.2 PRE-REQUISITE PROGRAMS
7.2.1 XYZ has made available a complete and actual description of the pre-requisite program (PRP) of the organization. The PRPs establish
- The likelihood of introducing food safety hazards to the product through the work environment.
- All classes of hazards (biological, physical and chemical) of the product/process, including cross contamination between the products.
- The level of food safety hazards in the product and product processing environment.
7.2.2 XYZ has identified the PRP’s as per the organizational needs, appropriate to the type of operational and product manufacture along the production system. And PRP’s are approved by Food Safety Team in compliance with PFA too.
7.2.3 XYZ has made available
• The procedures belonging to the PRP are well established (specified and documented), fully operational and integrated with the ISO 22000:2005 system, and verified. Their verification is addressed as a part of the Internal Audits and Verification activities.
• XYZ has decided which food hygiene principles, good manufacturing practices and food legislation are to be included into its PRP.
7.3 PRELIMINARY STEPS TO ENABLE HAZARD ANALYSIS 7.3.1 General
• The products and the processes, (the procedures belonging to) and the PRP are subjected to hazard analysis in order to identify potential hazards and to decide which way the hazards (risk) need to be controlled. This is demonstrated in the Hazard Identification and Risk Analysis of related products/processes, in the related HACCP/Food Safety Plans, as applicable. All the relavant information is collected, maintained, updated and documented. Records are available for the same.
7.3.2 Food safety team
• XYZ has assembled a Food Safety Team in order to develop, implement and maintain the ISO 22000 System. The team definition is available in the Food Safety Team document maintained with the FSTL. The team members have the knowledge, expertise and cover different disciplines available which are required to develop, implement and maintain a Food Safety Management System covering the entire scope of their operation. The competency of Food Safety Team Members is available and maintained with the FSTL, and is reviewed & updated periodically.
• The assignment (including tasks, responsibilities and authorities) are documented for the team members of the Food Safety Team as a part of the Responsibility and Authority document maintained with the FSTL.
7.3.3. PRODUCT CHARACTERISTICS
7.3.3.1 & 7.3.3.2 Raw materials, ingredients and product contact materials & characteristics of end products
• The quality specifications are defined for raw materials and ingredients. The product description for various food groups is specified and documented. The description of the safety of the product group encompasses the food chain, ranging from raw materials used to the distribution of the finished products. This is further documented through the Flow Diagrams and Hazard Analysis Work Sheets for the product group respectively
• An extensive specification of the end products ensures a comprehensive assessment of the food safety procedures. This specification clearly defines the following product characteristics:
− Product identification and general product description.
− Raw materials used and composition.
− General product specifications as per recipe.
− Specific requirements such as appropriate legislation.
− General control of (chemical, microbiological and physical) for food safety.
− Packaging, storage conditions, labeling.
− Identification of potential mishandling of the product.
7.3.4. INTENDED USE
• The intended use of the product is identified and documented for the product groups. Since this has a direct influence on the required product characteristics.
• The intended use of the product is continually reviewed.
7.3.5. FLOW DIAGRAMS, PROCESS STEPS AND CONTROL MEASURES
7.3.5.1 Flow diagrams
• XYZ has made available a complete and actual description of the operation in the form of flow diagrams (process steps), which are included in Food Safety Manual for the Flow Diagram, and layouts (production facilities), which are available with the FST Leader. When applying ISO 22000 to a given operation, consideration is given to steps preceding and following the specified operation, which is evidenced in the flow diagrams and Hazard Identification & Risk Analysis worksheet. These descriptions are drawn up and verified by the Food Safety and Validation Teams.
• The Flow Diagrams provide a schematic overview of the operation, and describe all the steps in sufficient detail to provide the Food Safety Team with adequate information for the ISO 22000. They take into account all relevant process steps, such as the manufacturing of the product, including critical points like:
− Disinfection of vegetables before use
− Pre-preparation
− Cooking
− Serving
• All facilities which are part of the infrastructure of XYZ, such as the production lines, storage areas and personnel facilities are depicted in layout plans. In the layout plans, the following items have been indicated:
− The routing of material, personnel. This is shown in the PLANT Layout.
− The areas and facilities for personnel use. This is shown in the PLANT Layout.
7.3.5.2 Description of process steps and control measures
• Prior to the execution of changes in the production process and layout that could adversely affect food safety, these changes are reported to the Food Safety Team in order to evaluate potential hazards to food safety, and take preventive actions accordingly. Prospective changes are reported to Food Safety Team as per the Documentation Control Procedure and its supporting documents.
• The accuracy and actuality of flow diagrams and layouts are verified by the Food Safety Team for compliance with the documented situation on a periodic basis (at least annually), in order to identify and document modifications to the process installation and layout. Verified flow diagrams and layouts, with changes marked on them if applicable, are maintained with the FSTL. These periodic verifications are a part of the Internal Audit cum Verification.
7.4 HAZARD ANALYSIS