G
GoKats78
If there is a process parameter called out on the control plan that is measured by a process gage and the process gage is found to not meet calibration requirements is there a requirement for a record to exist that assesses the impact of the out-of-specification condition?
7.6.2 Calibration/verification records
Records of the calibration/verification activity for all gauges, measuring and test equipment, needed to provide evidence of conformity of product to determined requirements, including employee- and customer-owned equipment, shall include
- equipment identification, including the measurement standard against which the equipment is calibrated,
- revisions following engineering changes,
- any out-of-specification readings as received for calibration/verification,
- an assessment of the impact of out-of-specification condition,
- statements of conformity to specification after calibration/verification, and
- notification to the customer if suspect product or material has been shipped.
7.6.2 Calibration/verification records
Records of the calibration/verification activity for all gauges, measuring and test equipment, needed to provide evidence of conformity of product to determined requirements, including employee- and customer-owned equipment, shall include
- equipment identification, including the measurement standard against which the equipment is calibrated,
- revisions following engineering changes,
- any out-of-specification readings as received for calibration/verification,
- an assessment of the impact of out-of-specification condition,
- statements of conformity to specification after calibration/verification, and
- notification to the customer if suspect product or material has been shipped.