QUALITY REPLAY: Pay Close Attention To Equipment Calibration Certificates, Experts Say; Device Firm Shares Tips

Executive Summary

From our digital archives: Devices manufactured with improperly calibrated equipment can pose a hidden risk for companies, experts say. Firms are urged to investigate if they discover that a product made with out-of-specification equipment has gone to market, and to review the work of third-parties that calibrate their manufacturing equipment. “What we typically see is that companies are blindly accepting calibration certificates from test houses,” former FDA official Kim Trautman says. Companies must determine and document how often equipment should be tested and calibrated, and need to keep a sharp eye on test houses just as they would any other supplier.