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| articles:as9100d_oe_requirements-1 [2019/08/18 18:42] – rrandall | articles:as9100d_oe_requirements-1 [2019/08/18 18:50] – rrandall |
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| ====== AS9100D Objective Evidence Requirements: Part 1 Documentation ====== | ====== AS9100D Objective Evidence Requirements: Part 1 Documentation ====== |
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| AS 9100D is an incredibly poorly written QMS standard littered with ambiguous / vague requirements that have resulted in subjective interpretations and inconsistent implementation. This article discusses the minimum "Objective Evidence" actually by the standard. Any interpretations beyond these minimum requirements (e.g., by an internal or external auditor) are based purely on subjective opinion. | AS 9100D is an incredibly poorly written QMS standard littered with ambiguous / vague requirements that have resulted in subjective interpretations and inconsistent implementation. This article discusses the minimum "Objective Evidence" actually required by the standard. Any interpretations beyond these minimum requirements (e.g., by an internal or external auditor) are based purely on subjective //opinion//. |
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| The first confusing point to address is which documentation (e.g., procedures) are actually required by AS 9100D. | The first confusing point to address is which documentation (e.g., procedures) are actually required by AS 9100D. |
| <note tip>**# 2 thru 8** \\ While AS 9100 does NOT require a "Quality Manual", it is generally a good idea to do so as a "defensive measure" because: \\ 1. Addressing all of the requirements of AS 9100D in a "Quality Manual" (at a policy level) the business can argue that it has addressed the more //subjective// requirements (contained throughout AS 9100D) that do not specifically require "objective evidence", and \\ 2. Including references to the sources for the business's interpretations can immediately dismiss many //subjective// interpretations that an auditor may have. \\ Also, a "Quality Manual" can improve efficiency through providing a single source addressing items 2 thru 8 from the above chart.</note> | <note tip>**# 2 thru 8** \\ While AS 9100 does NOT require a "Quality Manual", it is generally a good idea to do so as a "defensive measure" because: \\ 1. Addressing all of the requirements of AS 9100D in a "Quality Manual" (at a policy level) the business can argue that it has addressed the more //subjective// requirements (contained throughout AS 9100D) that do not specifically require "objective evidence", and \\ 2. Including references to the sources for the business's interpretations can immediately dismiss many //subjective// interpretations that an auditor may have. \\ Also, a "Quality Manual" can improve efficiency through providing a single source addressing items 2 thru 8 from the above chart.</note> |
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| <note important>**# 9** \\ The IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] states: //The 9100-series clause 7.1.5.2 was not intended to force organizations to have the register specifically include the "equipment type, unique identification, location, and the calibration or verification method, frequency, and acceptance criteria.” The organization is required to have this information for equipment listed on the calibration register but not specifically in the register.// \\ \\ Almost no one identifies the “method” or “acceptance criteria” in their “register” (database)... unless they have a full in-house calibration laboratory. What auditors typically see is: \\ 1. the “method” identified on the calibration certificate (from the calibration/metrology lab). \\ 2. the “acceptance criteria” either identified in the calibration certificate (from the calibration/metrology lab) OR for the company to have a copy of the calibration “method” that was used (containing the acceptance criteria). \\ \\ While the company could have the instrument specifications, if those specifications can’t be matched to the actual calibration method used, then there is no way to confirm that was the actual “acceptance criteria” used in performing the calibration. </note> | <note important>**# 9** \\ The IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] states: //The 9100-series clause 7.1.5.2 was not intended to force organizations to have the register specifically include the "equipment type, unique identification, location, and the calibration or verification method, frequency, and acceptance criteria.” The organization is required to have this information for equipment listed on the calibration register but not specifically in the register.// </note> |
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| | <note tip>**# 9** \\ Consistent with the above "official" interpretation, almost no one identifies the “method” or “acceptance criteria” in their “register” (database)... unless they have a full in-house calibration laboratory. What auditors typically see is: \\ 1. the “method” identified on the calibration certificate (from the calibration/metrology lab). \\ 2. the “acceptance criteria” either identified in the calibration certificate (from the calibration/metrology lab) OR for the company to have a copy of the calibration “method” that was used (containing the acceptance criteria). \\ \\ While the company could have the instrument specifications, if those specifications can’t be matched to the actual calibration method used, then there is no way to confirm that was the actual “acceptance criteria” used in performing the calibration. </note> |
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| <note important>**# 12** \\ When asked whether clause no. 8.5.1a) of ISO 9001:2015 "availability of documented information" means "maintain documented information”, the " | <note important>**# 12** \\ When asked whether clause no. 8.5.1a) of ISO 9001:2015 "availability of documented information" means "maintain documented information”, the " |
