GUIDANCE FOR AUDITORS The following is a non-exhaustive list of questions that an auditor can use to assess the FSSC Additional Requirement 2.5.15: • Are the purchase requirements established and known for all new equipment? • Is there supporting documentation available for review, such as purchase specifications, commissioning reports, equipment user manuals, certification documents, etc., to confirm the hygienic design of the equipment and successful commissioning? • Does it address the hygienic design of the equipment, the products handled, and the legal/customer requirements? • Has the intended use been clearly identified, and the risks related to the equipment determined? • Has a risk-based change-management process for new equipment or changes to existing equipment been established? • Have the relevant updates been made to the FSMS based on the changes made to equipment? E.g., cleaning and maintenance schedules updated, environmental monitoring program updated, evidence of training available?