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articles:auditing_7.1.5 [2023/07/20 20:24] – [Scenarios] rrandallarticles:auditing_7.1.5 [2024/07/09 08:54] (current) – [6 - Using a Precision Micrometer to calibrate Gage Blocks] rrandall
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 [[articles:auditing_7.1.5#using_a_precision_micrometer_to_calibrate_gage_blocks|Scenario #6:]] Similar to the above scenario, but at a different company, you discover that the company is using a Starrett W733.1XFL-1 Wireless Electronic Micrometer to calibrate their class AS-2 Gage Block set (stainless steel, rectangular 0.010" to 2"). While the Starrett W733.1XFL-1 Micrometer Calibration certificate contains minimal information, you notice that it has a digital display with a resolution of 0.00005". To verify that the Test Accuracy Ratio (T.A.R.) is sufficient, you see that the Gage Blocks Calibration Certificate indicates an accuracy of ±10 μin." (0.00001).  [[articles:auditing_7.1.5#using_a_precision_micrometer_to_calibrate_gage_blocks|Scenario #6:]] Similar to the above scenario, but at a different company, you discover that the company is using a Starrett W733.1XFL-1 Wireless Electronic Micrometer to calibrate their class AS-2 Gage Block set (stainless steel, rectangular 0.010" to 2"). While the Starrett W733.1XFL-1 Micrometer Calibration certificate contains minimal information, you notice that it has a digital display with a resolution of 0.00005". To verify that the Test Accuracy Ratio (T.A.R.) is sufficient, you see that the Gage Blocks Calibration Certificate indicates an accuracy of ±10 μin." (0.00001). 
  
-[[articles:auditing_7.1.5#fitness_for_purpose_1|Scenario #7:]] [[ https://www.qclabels.com/Quality-Control-Labels/Limited-Calibration-Control-Stickers.aspx|{{  :articles:lpc440.jpeg?200}}]]You observed calipers being used throughout the production process, and observed that the majority of these calipers supported the “Step” dimensional measurement. Upon interviewing multiple operators, you learned that some use the “Step” feature while others do not. You took note that NONE of these calipers with a “Step” feature had a “Limited Calibration" status label… and you were told that the calipers are calibrated in-house. Upon examining the Calibration record, you noticed that the “Step” feature was not included in the calibration results. It appears that the company has not been calibrating the "Step" feature on calipers that support this dimensional measurement.+[[articles:auditing_7.1.5#relocted_weighing_scale|Scenario #7:]] You observed a weighing scale with a calibration status label. Upon examining its associated Calibration Certificate, you notice that the certificate was issued to a different address than the location where the audit is being performed. Upon asking about this discrepancy, you're informed that the weighing scale was calibrated at a different location and shipped to the current location.
  
-[[articles:auditing_7.1.5#relocted_weighing_scale|Scenario #8:]] You observed a weighing scale with a calibration status label. Upon examining its associated Calibration Certificate, you notice that the certificate was issued to a different address than the location where the audit is being performed. Upon asking about this discrepancy, you're informed that the weighing scale was calibrated at a different location and shipped to the current location.+[[articles:auditing_7.1.5#fitness_for_purpose_1|Scenario #8:]] [[ https://www.qclabels.com/Quality-Control-Labels/Limited-Calibration-Control-Stickers.aspx|{{  :articles:lpc440.jpeg?200}}]]You observed calipers being used throughout the production process, and observed that the majority of these calipers supported the “Step” dimensional measurement. Upon interviewing multiple operators, you learned that some use the “Step” feature while others do not. You took note that NONE of these calipers with a “Step” feature had a “Limited Calibration" status label… and you were told that the calipers are calibrated in-house. Upon examining the Calibration record, you noticed that the “Step” feature was not included in the calibration results. It appears that the company has not been calibrating the "Step" feature on calipers that support this dimensional measurement.
  
 [[articles:auditing_7.1.5#fitness_for_purpose_2_as9100_only|Scenario #9 (AS 9100 ONLY):]] You observed micrometers being used throughout the production process, and you were told that the micrometers are calibrated "in-house". Upon Reviewing the Calibration Method, you noticed that neither the “flatness" nor “parallelism” of the anvil with the spindle had been calibrated. [[articles:auditing_7.1.5#fitness_for_purpose_2_as9100_only|Scenario #9 (AS 9100 ONLY):]] You observed micrometers being used throughout the production process, and you were told that the micrometers are calibrated "in-house". Upon Reviewing the Calibration Method, you noticed that neither the “flatness" nor “parallelism” of the anvil with the spindle had been calibrated.
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 (1) Is this a nonconformity? And if so, (2) is it a minor or a major nonconformity? (1) Is this a nonconformity? And if so, (2) is it a minor or a major nonconformity?
  
-__Answer:__ While this would appear to be a clear-cut nonconformity, it is not. This condition requires more information.+__Answer:__ It depends.
  
-==== Is this a nonconformity? ====+The auditor should ask whether the company has a "Calibration Management System" (CMS), or equivalent, procedure. \\  
 +If the answer is yes, then the auditor should review the CMS procedure because many companies provide themselves an //automatic// extension to the calibration interval/cycle/period (e.g., 30 days); or a conditional calibration due-date extension based upon management approval (to accept the increased risk). There are many good reasons why a company may choose to extend a calibration interval/cycle/period. However, the reason is typically to complete existing work in progress—accepting slightly greater risk in exchange for ensuring on-time completion/delivery of the product/service, or completion of a Project. This is perfectly acceptable.
  
 +I've seen CMS procedures that state: "//Calibration is due during the month identified on the calibration status label, without regard for the specific day identified.//" or "//Calibration is due within 45 days past the date identified on the calibration status label.//" This certainly satisfies the requirement in ISO 9001/AS9100, sec. 7.1.5.2a relating to specifying an "interval".
 +
 +{{ :articles:calibration-frequency-factors-768x1920.jpeg?direct&350|}}
 The auditor should understand and recognize that a measuring instrument does not //magically// go "Out of Tolerance" on a certain date. The calibration interval (cycle) is merely a "risk control" to mitigate: The auditor should understand and recognize that a measuring instrument does not //magically// go "Out of Tolerance" on a certain date. The calibration interval (cycle) is merely a "risk control" to mitigate:
-  - the likelihood of an instrument drifting out of tolerance without the user(s) knowledge, and+  - the likelihood of an instrument drifting out of tolerance during the calibration period, and
   - the impact/significance that an "Out-of-Tolerance" condition could have resulted in the shipment of nonconforming product(s) due to errors in measurements.   - the impact/significance that an "Out-of-Tolerance" condition could have resulted in the shipment of nonconforming product(s) due to errors in measurements.
-{{ :articles:calibration-frequency-factors-768x1920.jpeg?direct&350|}}+
 There are many factors that can contribute toward an instrument drifting out of tolerance, which include, but are not limited to: There are many factors that can contribute toward an instrument drifting out of tolerance, which include, but are not limited to:
   * Wear (due to frequent use—which is most common for dimensional measurement devices)   * Wear (due to frequent use—which is most common for dimensional measurement devices)
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   * Natural instrument degradation over time (e.g., aging of electronic components)     * Natural instrument degradation over time (e.g., aging of electronic components)  
  
-With this understanding, the auditor should ask whether the company has a "Calibration Management System" (CMS) procedure. \\  
-If the answer is yes, then the auditor should review the CMS procedure because many companies provide themselves an //automatic// extension to the calibration interval/cycle (e.g., 30 days); or a conditional calibration due-date extension based upon management approval (to accept the increased risk). There are many good reasons why a company may choose to extend a calibration interval/cycle. However, the reason is typically to complete existing work in progress—accepting slightly greater risk in exchange for ensuring on-time completion/delivery of the product/service, or completion of a Project. This is perfectly acceptable. 
  
-I've seen CMS procedures that state: "//Calibration is due during the month identified on the calibration status label, without regard for the specific day identified.//" and "//Calibration is due within 45 days past the date identified on the calibration status label.//" This certainly satisfies the requirement in ISO 9001/AS9100, sec. 7.1.5.2a relating to specifying an "interval". 
-<WRAP clear></WRAP> 
 <WRAP center round info 80%> <WRAP center round info 80%>
 While there is NO requirement in ISO 9001 / AS9100 to have a documented "Calibration Management System" (CMS), ISO 9001 / AS 9100, sec. 7.1.5.1 states: \\  While there is NO requirement in ISO 9001 / AS9100 to have a documented "Calibration Management System" (CMS), ISO 9001 / AS 9100, sec. 7.1.5.1 states: \\ 
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 ===== 6 - Using a Precision Micrometer to calibrate Gage Blocks ===== ===== 6 - Using a Precision Micrometer to calibrate Gage Blocks =====
    
-__Situation__ Similar to the above scenario, but at a different company, you discover that the company is using a [[https://www.starrett.com/metrology/product-detail/W733.1XFL-1#Specifications|Starrett W733.1XFL-1 Wireless Electronic Micrometer]] to calibrate their class AS-2 Gage Block set (stainless steel, rectangular 0.010" to 2"). While the Starrett W733.1XFL-1 Micrometer Calibration certificate contains minimal information, you notice that it has a digital display with a resolution of 0.00005" (50 μin.). To verify that the Test Accuracy Ratio (T.A.R.) is sufficient, you see that the Gage Blocks Calibration Certificate indicates an accuracy of ±10 μin. (±0.00001"). +__Situation__ Similar to the above scenario, but at a different company, you discover that the company is using a [[https://www.starrett.com/details?cat-no=W733.1XFL-1|Starrett W733.1XFL-1 Wireless Electronic Micrometer]] & [[https://www.starrett.com/details?cat-no=W733.1XFLZ-2|Starrett W733.1XFLZ-2 Wireless Electronic Micrometer]] a to calibrate their class AS-2 Gage Block set (stainless steel, rectangular 0.010" to 2"). While the Starrett W733.1XFL-1 Micrometer Calibration certificate contains minimal information, you notice that it has a digital display with a resolution of 0.00005" (50 μin.). To verify that the Test Accuracy Ratio (T.A.R.) is sufficient, you see that the Gage Blocks Calibration Certificate indicates an accuracy of ±10 μin. (±0.00001"). 
  
 <WRAP center round info 80%> <WRAP center round info 80%>
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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.
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  {{ youtube>NrLLmwi7-vE?large&rel=0 }}  {{ youtube>NrLLmwi7-vE?large&rel=0 }}
  
-===== 9 - The Incomplete "Register" (AS9100 ONLY) =====+===== 10 - The Incomplete "Register" (AS9100 ONLY) =====
  
 __Situation:__ Upon reviewing the company's "//register of the monitoring and measuring equipment//", which was maintained in an Excel spreadsheet, you discovered it did not include the: __Situation:__ Upon reviewing the company's "//register of the monitoring and measuring equipment//", which was maintained in an Excel spreadsheet, you discovered it did not include the: