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articles:auditing_7.1.5 [2023/07/20 20:24] – [9 - The Incomplete "Register" (AS9100 ONLY)] rrandallarticles: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? And if so, (2) is it a minor or a major 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://www.euramet.org/Media/docs/Publications/calguides/I-CAL-GUI-018_Calibration_Guide_No._18_web.pdf|EURAMET Calibration Guide No. 18 (Version 4.0 (11/2015))]], page 5, which states:  
 +<blockquote>**4.1.2 Place of calibration** \\  
 +Calibration is normally performed in the location where the instrument is being used. \\  
 + \\  
 +If an instrument is moved to another location after the calibration, possible effects from \\  
 +  - 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, the calibration certificate should 
 +not be accepted as evidence of traceability.</blockquote>  
 +===== 8 - Fitness for Purpose #1 =====
  
 [[ https://www.qclabels.com/Quality-Control-Labels/Limited-Calibration-Control-Stickers.aspx|{{  :articles:lpc440.jpeg?200}}]] [[ https://www.qclabels.com/Quality-Control-Labels/Limited-Calibration-Control-Stickers.aspx|{{  :articles:lpc440.jpeg?200}}]]
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-===== 8 - Fitness for Purpose #2 (AS9100 ONLY) =====+===== 9 - Fitness for Purpose #2 (AS9100 ONLY) =====
  
 __Situation:__ You observed micrometers being used throughout the production process; and you were told that the micrometers are calibrated "in-house". Upon reviewing the company's "//register of the monitoring and measuring equipment//" you discovered that they identify a calibration/verification method. Upon reviewing that calibration/verification method, you noticed that neither the “flatness" nor “parallelism” of the anvil with the spindle had been calibrated. You confirm this by examining calibration records for a sampling of the micrometers you observed in use. None of these records indicate that the “flatness" or “parallelism” of the anvil with the spindle had been calibrated. __Situation:__ You observed micrometers being used throughout the production process; and you were told that the micrometers are calibrated "in-house". Upon reviewing the company's "//register of the monitoring and measuring equipment//" you discovered that they identify a calibration/verification method. Upon reviewing that calibration/verification method, you noticed that neither the “flatness" nor “parallelism” of the anvil with the spindle had been calibrated. You confirm this by examining calibration records for a sampling of the micrometers you observed in use. None of these records indicate that the “flatness" or “parallelism” of the anvil with the spindle had been calibrated.