FDSA Audit Steps Revised-Aug07

NOTE: 2007 Revised Sections are Highlighted/Shaded FDSA Audit - Seven Steps to Quality Distribution Criteria Point Audit Steps Value I. RECEIVING PRODUCT: a. Instruction Sheets for each insert 1. Booking orders state flyer quantities and date(s). 10 2. If standing orders are not documented for each order; standing orders can be traced. 5 3. Orders list quantities and distribution geography. 10 b. Matching of quantities and versions received to insertion/delivery orders 1. Warehouse/Mailing Room has a vehicle (form, report, log, etc.) to match deliveries to orders. They 5 are complete – signed and dated. 2. Skid card/bills of lading to insertion order(s). Total quantities, dates and flyer description (or 10 identifying number) match delivery orders. c. Examining of condition of product for damage; relaying of concerns to printers, shippers and clients 1. Condition of flyers is examined upon receipt. 5 2. Damaged products are rejected; useable flyers are distributed. Warehouse notifies sales 10 department if distribution pattern is affected. 3. Sales rep contacts the advertiser and/or printer; instructions are relayed to warehouse. 10 4. Distributor retains sample copies of each delivery for quality control purposes. 5 5. Process exists for damaged product resolution. 5 d. Storage of sensitive material in a secure area 1. Distributor has assigned cages, shelves, or low-traffic areas in which to place sensitive products ...