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

Intended use The intended use of the building/equipment shall be specified

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 Buildings and equipment shall be of a cleanable design, to meet all cleaning objectives.

Hygienic design principles Buildings and equipment shall be designed and constructed to avoid favourable growth conditions (for microorganisms, pests and their harbourage), appropriate to their intended use.

Hygienic design principles Buildings and equipment shall be designed to prevent contamination appropriate to their intended use.

Hygienic design principles Wherever relevant, recognised hygienic design standards/guidance shall be consulted for the design and construction of buildings and equipment, appropriate for their intended use

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

Management responsibility A clear organisational structure identifying the job functions and responsibilities of at least those employees whose activities affect Hygienic Design shall be established, implemented and maintained.

Management commitment and food safety culture Evidence of the senior management’s commitment to establish, implement, maintain and continuously improve the Hygienic Design Management System shall be provided.

Management review The organisation’s senior management shall review the verification of the Hygienic Design System at planned intervals, to ensure their continuing suitability, adequacy and effectiveness.

Legislation Procedures shall be established, implemented and maintained to ensure that buildings and equipment are legally compliant in the hygienic design requirements in the country of known implementation / sale.

Hygienic Design Management System A Hygienic Design Management System shall be established, implemented, maintained and continuously improved.

Hygienic Design Policy A clear, concise and documented Hygienic Design policy statement shall be in place, as well as measurable objectives specifying the organisation’s commitments to meet the food safety needs of its products.

Documentation requirements A procedure shall be established, implemented, and maintained for the management and control of documented information required to demonstrate the effective operation and control of processes and the Hygienic Design Management System.

Documentation requirements All the above-mentioned documented information shall be securely stored for the time period required to meet customer and legal requirements, or for a period exceeding the lifetime of buildings/equipment if customer or legal requirements are not available. It shall be effectively controlled and readily accessible when needed

Specified requirements / Specifications Specified requirements or specifications shall be established, implemented and maintained for all inputs to the process, including services that are purchased or provided and have an effect on food safety.

Specified requirements / Specifications A review process of the specified requirements or specifications shall be in place.

Procedures Procedures and instructions shall be established, implemented and maintained for all processes and operations having an effect on food safety.

Resource management The resources needed to establish, implement, maintain, review and improve the Hygienic design Management System shall be identified and assigned

Purchasing and supplier performance A purchasing procedure shall be established, implemented and maintained to ensure that all inputs to the process including externally purchased materials and services which have an effect on food safety, conform to specified requirements as well as regulatory requirements.

Purchasing and supplier performance A procedure for the evaluation, approval and continued monitoring of suppliers which have an effect on food safety shall be established, implemented and maintained. The procedure shall address procurement in emergency situations to ensure buildings/equipment still confirms to the documented specified requirements or specification, and the supplier has been evaluated. The results of evaluations, investigations and follow-up actions shall be recorded.

Purchasing and supplier performance Outsourced processes or service that affect food safety shall be identified and controlled. Such controls shall be documented in the Hygienic Design Management System.

Traceability Procedures shall be established, implemented and maintained to ensure the ability to trace or follow a material or article critical to food safety through all stages of purchase, construction and distribution (minimum one step forward and one step backward)

Testing Where external testing of construction materials, buildings or equipment is required, it shall be carried out by an accredited testing facility or one that follows relevant international testing guidelines.

Testing Where in-house testing is carried out, calibration of equipment that is critical to food safety shall be carried out against national standards or other accurate mean

Internal audit An internal audit procedure shall be established, implemented and maintained; it shall cover all elements of the Hygienic Design Management System.

Complaint handling A procedure for the management of complaints and complaint data shall be established, implemented and maintained to ensure that complaints are assessed and corrective actions implemented, when necessary.

Serious incident management An incident management procedure, including product recall, withdrawal, and retrofit shall be established, implemented and maintained. The recall procedure shall be regularly tested for effectiveness.

Product release Commissioning or building/equipment release procedures shall be established, implemented and maintained.

Product release Hygienic design construction specifications shall be verified for buildings and equipment prior to dispatch or hand-over to the customer

Control of non-conformity A procedure shall be established, implemented and maintained to ensure that any non-conformity impacting food safety and any non-conforming products are clearly identified and controlled to prevent unintended use or delivery

Corrective actions A procedure shall be established, implemented and maintained for the determination and implementation of corrective actions in the event of any significant non- conformity relating to food safety.

Equipment The building in which equipment is manufactured shall be designed, constructed and maintained to minimise any contamination of the manufactured equipment which may affect food safety.

Product contamination risk and segregation Suitable employee, contractor and visitor access requirements shall be in place such that food safety is not compromised if construction is undertaken at a site in which food is being handled.

Product contamination risk and segregation Procedures shall be in place to prevent the cross- contamination of food from hazards created by construction activities if construction is undertaken at a site in which food is being handled.

Product contamination risk and segregation Prior to building commissioning or equipment dispatch, buildings / equipment shall be cleaned by the manufacturer / constructor using appropriate methods that will remove all food safety hazards associated with the construction process. 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 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

Training Procedure shall be established, implemented and maintained to ensure all employees and contractors involved in building construction and equipment installation, undertaken at a site handling food shall be trained in food safety principles appropriate to their task.

Pest control A procedure shall be established, implemented and maintained to prevent, monitor and control or eliminate the risk of pest infestation at the site

Transport Manufactured equipment shall be stored and transported to the final customer in a manner that prevents contamination of the equipment which may affect food safety.