In this conversation, Anne, Kim, and Steven discuss where to start when conducting an audit. They suggest asking for a list of deviations, change controls, and out-of-specifications (OOS) results before going on the tour. They also recommend requesting these lists in an Excel format for easier searching. Other starting points include reviewing batch records, the site validation master plan, the quality manual or site master plan, and the standard operating procedure (SOP) list. They also emphasize the importance of looking at annual product reviews, overdue calibrations and preventive maintenance, and data integrity in computer systems. Additionally, they discuss the value of walking through batch records and processes, checking management reviews and trending, and paying attention to pest control and warehouse areas.
