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articles:as9100d_oe_requirements-2 [2019/08/24 11:38] rrandallarticles:as9100d_oe_requirements-2 [2023/05/14 21:39] (current) rrandall
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 ====== AS9100D Objective Evidence Requirements: Part 2 Records ====== ====== AS9100D Objective Evidence Requirements: Part 2 Records ======
- +{{keywords>AS9100 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 required by the standard. Any interpretations beyond these minimum requirements (e.g., by an internal or external auditor) are based purely on subjective //opinion//+<WRAP button>[[articles:as9100d_oe_requirements-1|Part 1 Documentation]]</WRAP> 
 +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 actually 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".
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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  |
 |  5  | The organization shall plan, implement, and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in clause 6, by: \\ e. determining, maintaining, and //**retaining documented information**// __to the extent necessary__: \\ 1. to have confidence that the processes have been carried out as planned; \\ 2. to demonstrate the conformity of products and services to their requirements; \\ <wrap em>**[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor.]**</wrap> |  8.1.e  | |  5  | The organization shall plan, implement, and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in clause 6, by: \\ e. determining, maintaining, and //**retaining documented information**// __to the extent necessary__: \\ 1. to have confidence that the processes have been carried out as planned; \\ 2. to demonstrate the conformity of products and services to their requirements; \\ <wrap em>**[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor.]**</wrap> |  8.1.e  |
 |  6  | 8.2.3 Review of the Requirements for Products and Services \\ 8.2.3.2 The organization shall //**retain documented information**//, __as applicable__: \\ a. on the results of the review; \\ b. on any new requirements for the products and services. |  8.2.3.2  | |  6  | 8.2.3 Review of the Requirements for Products and Services \\ 8.2.3.2 The organization shall //**retain documented information**//, __as applicable__: \\ a. on the results of the review; \\ b. on any new requirements for the products and services. |  8.2.3.2  |
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 |  **27**  | 10.2.2 The organization shall //**retain documented information**// as evidence of: \\ a. the nature of the nonconformities and any subsequent actions taken; \\ b. the results of any corrective action. |  10.2.2  | |  **27**  | 10.2.2 The organization shall //**retain documented information**// as evidence of: \\ a. the nature of the nonconformities and any subsequent actions taken; \\ b. the results of any corrective action. |  10.2.2  |
  
 +<WRAP center round important 80%>**# 1** \\ When reading AS9100, sec. 4.4.2b, the interpretation that any additional records are to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor, is supported by interpretations relating to ISO 9001:2008 in "ISO/TC 176/SC 2 Listing of Approved Interpretations against ISO 9001:2008" (Version V1, 2011-02): \\ - RFI (Request for Interpretation)# 111 asked "Does Clause 6.3 require records of the maintenance of infrastructures?". The official interpretation was a simple "No". \\ - RFI# 115 asked "Does Clause 7.4.3 require records of the verification of purchased product?". The official interpretation was a simple "No". \\ \\ Because neither of these records are specifically required in ISO 9001:2015, the same logic remains in effect.</WRAP>
  
-<note important>**# 1** \\ When reading AS9100sec. 4.4.2b, the interpretation that any additional records are to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor, is supported by interpretations relating to ISO 9001:2008 in "ISO/TC 176/SC 2 Listing of Approved Interpretations against ISO 9001:2008" (Version V1, 2011-02): \\ RFI (Request for Interpretation)# 111 asked "Does Clause 6.3 require records of the maintenance of infrastructures?". The official interpretation was a simple "No". \\ - RFI# 115 asked "Does Clause 7.4.3 require records of the verification of purchased product?". The official interpretation was a simple "No". \\ \\ Because neither of these records are specifically required in ISO 9001:2015, the same logic remains in effect.</note>+<WRAP center round tip 80%>**# 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 4:1in their [[https://www.utc.com/suppliers/aerospace-supplier-quality-requirement-documents|United Technologies ASQR-01 (Rev. 11), sec5.4.1]].</WRAP>
  
-<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 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 (Rev11), sec5.4.1]].</note>+<WRAP center round tip 80%>**# 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 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"]].</WRAP>
  
-<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>+<WRAP center round tip 80%> 
 +**# 4** \\ For guidance on addressing AS 9100, clause 7.2d, see the (non-binding) IAF  
 +[[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/ISO%209001%20Auditing%20Practices%20Group%20docs/Auditing%20to%20ISO%209001%202015/APG-Competence2015.pdf|ISO 9001 Auditing Practices Group Guidance on: Competence]]. 
 +</WRAP>
  
-<note tip>**# 4** \\ For guidance on addressing AS 9100, clause 7.2d, see the (non-binding) IAF  +<WRAP center round info 80%>**# 15** \\ The IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] states: //Clause 8.5.1.n requires evidence that all production and inspection/verification operation steps have been completed as planned or otherwise documented and authorized. Examples of evidence can include stamps, electronic signatures, initials, or names.//</WRAP>
-[[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/ISO%209001%20Auditing%20Practices%20Group%20docs/Auditing%20to%20ISO%209001%202015/APG-Competence2015.pdf|ISO 9001 Auditing Practices Group Guidance onCompetence]].</note>+
  
-<note important>**# 15** \\ The IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] states: //Clause 8.5.1.n requires evidence that all production and inspection/verification operation steps have been completed as planned or otherwise documented and authorizedExamples of evidence can include stampselectronic signaturesinitials, or names.//</note>+<WRAP center round info 80%>**# 18** \\ In response to the question: "//Does 9100 require production process verification of all assemblies?//", the IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] states: //It depends. The organization defines its production process verification process to cover parts and assemblies. Assembly can include subassemblies, component assemblies, and even final product.// \\ In response to the question: "//Does 9100 mandate that a Production Process Verification be performed and the fixture verified to the first article if the tooling fixtures in the factory have been disassembled and moved to another location within the same facility?//", the IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] states: "//Yes. It is expected that the organization would have some tool verification activity, commensurate with the amount of tool disassembly, to ensure the fixture is still capable of building conforming hardware. It is thought that disassembly and reassembly of a fixture would be specified as one of the requirements that would invalidate the previous PPV.//" \\ \\ The IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] also provides clarification of this clause stating: "//The first clause 8.5.1.3 requirement was introduced so all organizations, including those with small production quantities (such as in Space industry), could apply the Production Process Validation (PPV) instead of identifying it as not applicable (exclusion). The Team wanted to open the door for other “process” methods to perform PPV that may be implemented to provide an alternative methodology to the previously written PPV requirement. The team decided to keep the second requirement for all the organizations as a FAI can be done according to internal rules (or according to the 9102 when required by contract)\\ The first paragraph was added since only performing a FAI does not provide the warranty that the whole "production" process will be able to product parts that meet requirements. Actually, it only provides the warranty that the "manufacturing" process is able to "manufacture" a product compliant with the requirements relating to the "product." The other requirements regarding the "production" process (in terms of quantities to producelead-timecost constraints...) cannot be verified with only a FAI. It was not the team's intent to require PPAP or process capability for each production process. 
 +Regarding the "records" we require the organization to retain documented information on how they ensure production process verification is implemented.//"</WRAP>
  
-<note important>**# 18** \\ In response to the question: "//Does 9100 require production process verification of all assemblies?//"the IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] states: //It depends. The organization defines its production process verification process to cover parts and assembliesAssembly can include subassembliescomponent assemblies, and even final product.// \\ In response to the question: "//Does 9100 mandate that a Production Process Verification be performed and the fixture verified to the first article if the tooling fixtures in the factory have been disassembled and moved to another location within the same facility?//", the IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] states: "//Yes. It is expected that the organization would have some tool verification activity, commensurate with the amount of tool disassembly, to ensure the fixture is still capable of building conforming hardware. It is thought that disassembly and reassembly of a fixture would be specified as one of the requirements that would invalidate the previous PPV.//" \\ \\ The IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] also provides clarification of this clause stating: "//The first clause 8.5.1.3 requirement was introduced so all organizations, including those with small production quantities (such as in Space industry), could apply the Production Process Validation (PPV) instead of identifying it as not applicable (exclusion). The Team wanted to open the door for other “process” methods to perform PPV that may be implemented to provide an alternative methodology to the previously written PPV requirementThe team decided to keep the second requirement for all the organizations as a FAI can be done according to internal rules (or according to the 9102 when required by contract). \\ The first paragraph was added since only performing a FAI does not provide the warranty that the whole "production" process will be able to product parts that meet requirementsActually, it only provides the warranty that the "manufacturing" process is able to "manufacture" a product compliant with the requirements relating to the "product." The other requirements regarding the "production" process (in terms of quantities to producelead-time, cost constraints, ...) cannot be verified with only a FAI. It was not the team's intent to require PPAP or process capability for each production process. +<WRAP center round important 80%> 
-Regarding the "records" we require the organization to retain documented information on how they ensure production process verification is implemented.//"</note>+**# 26** \\ AS9100/ISO 9001sec"9.3.2 Management Review Inputs" states: \\ The management review shall be planned and carried out taking into consideration: \\ cinformation on the performance and effectiveness of the quality management systemincluding trends in: \\ 2the __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.// \\ \\ However, when asked "//Is it the intent of the standard that an organization can have just a top-level requirement(s) that is used to evaluate the effectiveness of the QMS and several individual processes without those processes having specific metrics? For exampleOTD of product to the customer of 98% is the top-level metric and the metric used to evaluate the effectiveness of the purchasing process, contract review process, and the manufacturing process with no additional metrics. So if they have met the OTD of 98%, then all processes are deemed as effective.//" (relating to sec. 4.4.1c & g), the IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] responded: "//No. 9100-series standards require the organization to determine if the identified processes are effective and achieving planned results (see clause 4.4.1c)Each process measure should evaluate the effectiveness of that process and be value-addedThis is the measure that would be included in Process Effectiveness Assessment Report (PEAR) as the key performance indicator for that process. \\ The 9100-series standards does not mandate a certain number of process measuresSmall organizations typically have fewer measures than larger organizationsThese small organizations have increased visibility regarding process health due to their size. Regardlessthis does not alleviate the need for determining if processes are effective and achieving planned resultsThe organization can have additional working level measures that may not flow up to top management or management review.//" 
 +</WRAP>
  
-<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....shall establish objectives at "relevant" processes...It may NOT be relevant to set an objective for some processes.// \\ \\ However, when asked "//Is it the intent of the standard that an organization can have just top-level requirement(s) that is used to evaluate the effectiveness of the QMS and several individual processes without those processes having specific metrics? For exampleOTD of product to the customer of 98% is the top-level metric and the metric used to evaluate the effectiveness of the purchasing process, contract review process, and the manufacturing process with no additional metrics. So if they have met the OTD of 98%, then all processes are deemed as effective.//" (relating to sec. 4.4.1c & g), the IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] responded"//No. 9100-series standards require the organization to determine if the identified processes are effective and achieving planned results (see clause 4.4.1c). Each process measure should evaluate the effectiveness of that process and be value-added. This is the measure that would be included in Process Effectiveness Assessment Report (PEAR) as the key performance indicator for that process. \\ The 9100-series standards does not mandate a certain number of process measures. Small organizations typically have fewer measures than larger organizations. These small organizations have increased visibility regarding process health due to their size. Regardless, this does not alleviate the need for determining if processes are effective and achieving planned results. The organization can have additional working level measures that may not flow up to top management or management review.//"</note>+<WRAP center round important 80%> 
 +**# 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: //YesExperts 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 evidencethat 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”.//  
 +</WRAP>
  
-<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>+{{page>wiki:pathforward}}