Deviation Evaluation
Post-calibration procedures investigate the consequences of an instrument being found to operate outside its specified limits. An out-of-tolerance analysis evaluates the magnitude of the deviation and determines when the error began. This evaluation is critical for ensuring the validity of previous measurements.
Root Cause
Technical investigations seek to identify the underlying reasons for the calibration drift. Factors such as environmental stress, component wear or physical damage are analyzed to understand why the instrument exceeded its limits. Finding the root cause prevents the issue from recurring in future operating cycles.
Impact Assessment
Quality engineers review the data collected by the faulty instrument to determine if it affected product quality. They must assess whether the measurement error could have caused bad product to be accepted or good product to be rejected. This assessment is documented to satisfy regulatory requirements and maintain product safety.
In some cases, this review can trigger a recall of products that were manufactured while the instrument was operating outside of its acceptable limits.
Corrective Action
Remedial steps are taken to adjust or replace the failing instrument and prevent future occurrences. These actions include updating the calibration frequency, modifying the operating environment or training personnel on correct handling procedures. This final phase of the analysis ensures that the measurement system returns to a reliable state.