The two biggest lies when the Auditor makes a surprise visit:
Manufacturer: “Good to see you.”
Auditor: “I’m only here to help.”
Medical device manufacturers are accustomed to seeing auditors. There are the “independent” auditors hired by the manufacturer to visit twice a year just to test the systems and make sure that everything is in place. Then there are the insurance accreditation auditors, plus the OEM’s internal and external auditors for subcontract work, the ISO 13485:2003 certification auditors, and the big daddy of them all – the FDA. For even the well prepared, the heart still skips a beat and the chest tightens a bit when the auditor walks through the door.
MISys Manufacturing can help. The Serial Lot Tracking module of MISys was designed to trace raw materials, sub-assemblies and finished goods in inventory. MISys silently logs every transaction involving a serialized or lot tracked items through physical inventory, purchasing and production. Manufacturers using Serial Lot Tracking can easily generate detailed audit reports to satisfy virtually any regulatory agency, giving them confidence to say:
“We’re in great shape. I look forward to your report.”