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| articles:auditing_7.1.5 [2023/07/20 20:25] – [8 - Fitness for Purpose #2 (AS9100 ONLY)] rrandall | articles:auditing_7.1.5 [2023/07/20 20:55] – [7 - Relocted Weighing Scale] rrandall | ||
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| A major nonconformity is clearly justified. | A major nonconformity is clearly justified. | ||
| - | ===== 7 - Fitness for Purpose #1 ===== | + | ===== 7 - Relocted Weighing Scale ===== |
| + | |||
| + | __Situation__ A weighing scale was calibrated at a different location and then shipped to its current location. And there is no evidence that the calibration was repeated to verify that the weighing scale remained in-tolerance following the move. | ||
| + | |||
| + | (1) Is this a nonconformity? | ||
| + | |||
| + | __Answer:__ The proper follow-up question is whether there is any documentation or record indicating that this specific model of weighing scale is immune from possible effects of \\ | ||
| + | - the difference in local gravity acceleration, | ||
| + | - variation in environmental conditions, and/or \\ | ||
| + | - mechanical and thermal conditions during transportation that likely altered the performance of the instrument? \\ | ||
| + | |||
| + | If the answer is no, and there is no other evidence to the contrary, this should be a Major nonconformance because we must assume that there is a high degree of probability that product quality (or quantity) has been affected. However, if the auditee has appropriate test weights (mass) providing an acceptable calibration accuracy ratio, and can verify that the weighing scale is in-tolerance during the audit, then this can be graded as a Minor Nonconformity (for not having a record of calibration AFTER the weighing scale was re-located). | ||
| + | |||
| + | The basis for this nonconformity is found in [[https:// | ||
| + | < | ||
| + | Calibration is normally performed in the location where the instrument is being used. \\ | ||
| + | \\ | ||
| + | If an instrument is moved to another location after the calibration, | ||
| + | - difference in local gravity acceleration, | ||
| + | - variation in environmental conditions, \\ | ||
| + | - mechanical and thermal conditions during transportation are likely to alter the performance of the instrument and may invalidate the calibration. \\ | ||
| + | Moving the instrument after calibration should therefore be avoided, unless immunity to these effects of a particular instrument, or type of instrument has been clearly demonstrated. Where this has not been demonstrated, | ||
| + | not be accepted as evidence of traceability.</ | ||
| + | ===== 8 - Fitness for Purpose #1 ===== | ||
| [[ https:// | [[ https:// | ||
