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--- articles:as9100d_oe_requirements-2 [2019/08/18 11:01] – rrandall
+++ articles:as9100d_oe_requirements-2 [2019/08/18 18:52] – rrandall
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 ====== AS9100D Objective Evidence Requirements: Part 2 Records ======
-As mentioned in Part 1, 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 mentioned in Part 1, 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//.
-The second confusing point to address is which "records" are any actual required by AS 9100D. First, let's look at how ISO 9001:2015 defines a "record".
+The second confusing point to address is which "records" are actually required by AS 9100D. First, let's look at how ISO 9001:2015 defines a "record".
 AS 9100:2016 (Rev. D) Annex A states:
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 <note tip>**# 2** \\ Because AS 9100D fails to adequately address "//fitness for purpose//", knowledgable Aerospace companies such as Collins Aerospace (previously UTAS) & Pratt & Whitney identify a minimum "//accuracy ratio//" for M&TE (as 4:1) in their [[https://www.utc.com/suppliers/aerospace-supplier-quality-requirement-documents|United Technologies ASQR-01 (Rev. 11), sec. 5.4.1]].</note>
-<note tip>**# 3** \\ 1. To begin clause 7.1.5.2 with the words "//When measurement traceability is a requirement...//" seems odd because ALL M&TE should have metrological traceability. While it has been speculated that this requirement is intentionally vague so as to also encompass subjective "measuring tools" (e.g., customer satisfaction surveys), due to this ambiguity, most AS 9100 auditors simply interpret this as a requirement for "calibration" (a.k.a. "Metrological Confirmation") records. The bottom line is, if ISO / IAQG had wanted something different, they should have been more specific. \\ 2. For clause 7.1.5.2a to require metrological traceability to "to international or national measurement standards" indicates either an ignorance on the part of ISO / IAQG concerning metrological traceability OR the influence of government members mandating the use of government funded NMIs (National Metrology Institutes). In either case, this is an antiquated way in which to address metrological traceability. To gain a better understanding of metrological traceability, read "[[articles:nist_traceability|NIST Traceability Numbers - The Sasquatch of Metrology]].</note>
+<note tip>**# 3** \\ 1. To begin clause 7.1.5.2 with the words "//When measurement traceability is a requirement...//" seems odd because ALL M&TE should have metrological traceability. While it has been speculated that this requirement is intentionally vague so as to also encompass subjective "measuring tools" (e.g., Visual Representations (photographs), Representative Samples, Customer Satisfaction Surveys), due to this ambiguity, most AS 9100 auditors simply interpret this as a requirement for "calibration" (a.k.a. "Metrological Confirmation") records. The bottom line is, if ISO / IAQG had wanted something different, they should have been more specific. \\ 2. For clause 7.1.5.2a to require metrological traceability to "to international or national measurement standards" indicates either an ignorance on the part of ISO / IAQG concerning metrological traceability OR the influence of government members mandating the use of government funded NMIs (National Metrology Institutes). In either case, this is an antiquated way in which to address metrological traceability. To gain a better understanding of metrological traceability, read "[[articles:nist_traceability|NIST Traceability Numbers - The Sasquatch of Metrology]].</note>
 <note tip>**# 4** \\ For guidance on addressing AS 9100, clause 7.2d, see the (non-binding) IAF
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 <note important>**# 26** \\ AS9100/ISO 9001, sec. "9.3.2 Management Review Inputs" states: \\ The management review shall be planned and carried out taking into consideration: \\ c. information on the performance and effectiveness of the quality management system, including trends in: \\ 2. the __extent to which quality objectives have been met__; \\ \\ When asked "//Is every process established by an organization required to have at least one quality objective?//" (ref. AS9100/ISO 9001sec. 6.2.1), the official response provided in the "[[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]]" (US# 2018-04) stated: // No. (6.2.1 ...shall establish objectives at "relevant" processes...) It may NOT be relevant to set an objective for some processes.//</note>
-<note important>**# 27** \\ When asked "//Is it a requirement of ISO 9001:2015, Subclause 10.2, to document the root cause analysis?//", the official response provided in the "[[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/Interpretations/ISO9001_2015_Approved_Interpretations.doc|ISO/TC 176/SC 2 Listing of Approved Interpretations against ISO 9001:2015]]" (RFI# 134) stated: //No. This is because ISO 9001 does not address “root cause analysis”.//</note>
+<note important>**# 27** \\ When asked "//If action is taken under section 10.2.1, c) that addresses a cause, but not the "root" cause (e.g., 1 why vs. 5 whys), is a review of the effectiveness of corrective action (part d) required?//", the the official response provided in the "[[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]]" (US# 2019-01) stated: //Yes. Experts agree that the intent of 10.2.1d (review the effectiveness of any corrective action taken) is to ensure that the organization manages nonconformities, and implements corrective action, appropriately. \\ ISO/TS 9002:2016 states in Clause 10.2.1, "The organization should review the effectiveness of any corrective actions by confirming (through evidence) that the actions have been implemented or correction taken and as a result the nonconformities have not recurred."// \\ \\ However, when asked "//Is it a requirement of ISO 9001:2015, Subclause 10.2, to __document__ the root cause analysis?//", the official response provided in the "[[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/Interpretations/ISO9001_2015_Approved_Interpretations.doc|ISO/TC 176/SC 2 Listing of Approved Interpretations against ISO 9001:2015]]" (RFI# 134) stated: //No. This is because ISO 9001 does not address “root cause analysis”.// </note>