GFSI J2 PRODUCTION OF BIO

Hygienic design process A competent multidisciplinary team shall assess the hygienic design and risk assessment of new and existing buildings/equipment.

Hygienic design process The hygienic design and suitability of buildings and equipment shall be evaluated throughout their life cycle from the design concept, through construction, purchasing and during use, until the end of their intended life.

Risk assessment A documented hygienic design risk assessment for food safety hazards on new and existing buildings/ equipment shall be established, implemented and maintained. It shall include as a minimum the following considerations: intended use, food safety hazard identification, evaluation.

Risk assessment The hygienic design risk assessment shall be reviewed when any change to the building/equipment/product/ process is made or other hazards arise, or at a minimum frequency defined by applicable laws and regulations

Intended use The intended use of the building/equipment shall be described, as a specification for the intended purchase of new buildings and equipment

Hygienic design principles Appropriate building/equipment hygienic design principles shall be adopted based on the designated risk assessment, appropriate to their intended use and taking into consideration a user specification.

Hygienic design principles Appropriate hygienic design principles shall be adopted for the installation of new equipment and construction of buildings at sites handling food

Hygienic design principles Hygienic design principles shall be adopted to ensure the maintenance of the hygienic performance of the buildings/equipment, appropriate for their intended use.

Hygienic design mitigation Appropriate measures (with frequencies) shall be specified, undertaken accordingly and documented to mitigate any remaining food safety risks identified in the hygienic design risk assessment following building/ equipment construction, purchase and installation.

Purchasing and supplier performance A procedure shall be established, implemented and maintained to ensure that the newly purchased building/ equipment meets the hygienic design specification

Change management Change control shall be undertaken and documented to evaluate the impacts of any changes/ modifications on equipment/building hygienic design.

Product contamination risk and segregation Following purchase (and installation), all buildings and equipment shall be cleaned/commissioned by the user before they are used for the processing of food. Cleaning should be recorded and verified.

Training Procedures shall be established, implemented and maintained to ensure all employees and contractors involved in building and equipment evaluation, specification, purchase, maintenance and hygienic design shall be trained in hygienic design principles appropriate to their tasks and to the hygienic design requirements of the building or equipment for its intended use.