750-FRM-0188 X-Ray Quality Control Check Control Point (CP)

Frequency: the X-ray detectors must be verified within 60 minutes following the start up of each shift, at the middle of each shift and at the end of production. Once a day the x-Ray should be checked by passing the three consecutive standards in the center of the detector. Reference Standards: only the standards 1.5mm Ferrous, 1.5mm Non-Ferrous, and 2.0mm Stainless Steel are taken into account for the CCP monitoring. All standards must be passed through the unit individually to monitor their proper detection and rejection. Deviation Procedure: If a critical x-Ray reference standard is not detected or rejected properly you must: 1. STOP THE LINE. 2. All product since the last monitoring must be physically isolated, properly tagged and placed on S HOLD in SAP. 3. Contact your Quality Manager immediately. 4. Product must be passed under a good functioning metal detector or x-Ray. 5. Complete deviation report F-Q-110A. NOTE: in case of detections recorded by a detector during production, complete the DETECTION section.