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| articles:as9100d_oe_requirements-2 [2020/01/22 20:19] – rrandall | articles:as9100d_oe_requirements-2 [2021/04/18 09:27] – rrandall |
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| ^ # ^ “Retained” as Documented Information (Records) ^ Sec. ^ | ^ # ^ “Retained” as Documented Information (Records) ^ Sec. ^ |
| | **1** | //To the extent necessary//, the organization shall: \\ b. //**retain documented information**// to have confidence that the processes are being carried out as planned. \\ <wrap em>**[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor.]**</wrap> | 4.4.2b | | | **1** | //To the extent necessary//, the organization shall: \\ b. //**retain documented information**// to have confidence that the processes are being carried out as __planned__. \\ <wrap em>**[While this requirement is SUBJECTIVE, it is clarified in: \\ |
| | **2** | The organization shall //**retain __appropriate__ documented information**// as evidence of fitness for purpose of the monitoring and measurement resources. \\ <wrap em>**[SUBJECTIVE requirement - because AS 9100D fails to adequately address this topic]**</wrap> | 7.1.5.1 | | 7.5.1 General \\ |
| | The organization’s quality management system shall include: \\ |
| | • documented information required by this International Standard; \\ |
| | • documented information DETERMINED BY THE ORGANIZATION as being necessary for the effectiveness of the quality management system. \\ |
| | \\ |
| | AND Annex A.6 \\ |
| | “THE ORGANIZATION is responsible for determining what documented information needs to be retained, the period of time for which it is to be retained, and the media to be used for its retention." \\ |
| | \\ |
| | NOTE: //Some// ACCREDITATION BODY AUDITORS from ANAB have incorrectly interpreted 4.4.2b to mean that EVERYWHERE the standard uses the word "PLAN", there must be an associated record. This would significantly expand the number of records required. However, the AS9100 IDR has stated that this interpretation was incorrect.] \\ |
| | **</wrap> | 4.4.2b | |
| | | **2** | The organization shall //**retain __appropriate__ documented information**// as evidence of fitness for purpose of the monitoring and measurement resources. \\ <wrap em>**[SUBJECTIVE requirement - because AS 9100D fails to adequately define what is considered to be __appropriate__ .]**</wrap> | 7.1.5.1 | |
| | **3** | When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: \\ a. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be //**retained as documented information**//; | 7.1.5.2a | | | **3** | When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: \\ a. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be //**retained as documented information**//; | 7.1.5.2a | |
| | **4** | The organization shall: \\ // d. **retain __appropriate__ documented information**// as evidence of competence. | 7.2d | | | **4** | The organization shall: \\ // d. **retain __appropriate__ documented information**// as evidence of competence. | 7.2d | |
| <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>**# 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> |
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| <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 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]]. \\ BTW, The clarification concerning metrological traceability includes the statement "//The organization may have regulatory requirements to have standards traceable to NAA.//" (which is possible where regulators do not understand the definition of "metrological traceability" contained in [[https://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2012.pdf|BIPM JCGM 200]]). The acronym "NAA" is intended to be understood to mean [[https://en.wikipedia.org/wiki/National_aviation_authority|"National Aviation Authority"]]</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 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]]. \\ BTW, The clarification concerning metrological traceability includes the statement "//The organization may have regulatory requirements to have standards traceable to NAA.//" (which is possible where regulators do not understand the definition of "metrological traceability" contained in [[https://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2012.pdf|BIPM JCGM 200]]). The acronym "NAA" is intended to be understood to mean [[https://en.wikipedia.org/wiki/National_aviation_authority|"National Aviation Authority"]].</note> |
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| <note tip>**# 4** \\ For guidance on addressing AS 9100, clause 7.2d, see the (non-binding) IAF | <note tip>**# 4** \\ For guidance on addressing AS 9100, clause 7.2d, see the (non-binding) IAF |
