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articles:auditing_7.1.5 [2023/07/20 20:57] – [Scenarios] rrandall | articles:auditing_7.1.5 [2024/07/09 08:54] (current) – [6 - Using a Precision Micrometer to calibrate Gage Blocks] rrandall |
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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? |
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__Answer:__ While this would appear to be a clear-cut nonconformity, it is not. This condition requires more information. | __Answer:__ It depends. |
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==== 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. |
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| 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". |
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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. |
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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) |
* Natural instrument degradation over time (e.g., aging of electronic components) | * Natural instrument degradation over time (e.g., aging of electronic components) |
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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. | |
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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". | |
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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: \\ |
===== 6 - Using a Precision Micrometer to calibrate Gage Blocks ===== | ===== 6 - Using a Precision Micrometer to calibrate Gage Blocks ===== |
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__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"). |
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