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articles:as9100d_oe_requirements-2 [2019/08/18 21:32]
rrandall
articles:as9100d_oe_requirements-2 [2019/08/24 11:38] (current)
rrandall
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 +A row number below in **Bold** indicates either "​Tips"​ or "​Interpretations"​ are associated with the requirement(s). \\
  
 ^  #  ^  “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>​**[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor.]**</​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 address this topic]**</​wrap>​ |  7.1.5.1 ​ | +|  ​**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 ​ | 
-|  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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 |  13  | 8.4.1.1 The organization shall: \\ b. //​**maintain a register**//​ of its external providers that includes approval status (e.g., approved, conditional,​ disapproved) and the scope of the approval (e.g., product type, process family); |  8.4.1.1 ​ | |  13  | 8.4.1.1 The organization shall: \\ b. //​**maintain a register**//​ of its external providers that includes approval status (e.g., approved, conditional,​ disapproved) and the scope of the approval (e.g., product type, process family); |  8.4.1.1 ​ |
 |  14  | When externally provided product is released for production use pending completion of all required verification activities, it shall be identified and //​**recorded**//​ to allow recall and replacement if it is subsequently found that the product does not meet requirements. |  8.4.2  | |  14  | When externally provided product is released for production use pending completion of all required verification activities, it shall be identified and //​**recorded**//​ to allow recall and replacement if it is subsequently found that the product does not meet requirements. |  8.4.2  |
-|  15  | Controlled conditions shall include, as applicable: \\ n. the availability of //​**evidence**//​ that all production and inspection/​verification operations have been completed as planned, //**or as otherwise documented**//​ and authorized; ​  ​| ​ 8.5.1n ​ |+|  ​**15**  | Controlled conditions shall include, as applicable: \\ n. the availability of //​**evidence**//​ that all production and inspection/​verification operations have been completed as planned, //**or as otherwise documented**//​ and authorized; ​  ​| ​ 8.5.1n ​ |
 |  16  | Controlled conditions shall include, as applicable: \\ q. the identification and //​**recording**//​ of products released for subsequent production use pending completion of all required measuring and monitoring activities, to allow recall and replacement if it is later found that the product does not meet requirements. |  8.5.1q ​ | |  16  | Controlled conditions shall include, as applicable: \\ q. the identification and //​**recording**//​ of products released for subsequent production use pending completion of all required measuring and monitoring activities, to allow recall and replacement if it is later found that the product does not meet requirements. |  8.5.1q ​ |
 |  17  | 8.5.1.2 Validation and Control of Special Processes \\ For processes where the resulting output cannot be verified by subsequent monitoring or measurement,​ the organization shall establish arrangements for these processes including, as applicable: \\ f. requirements for //​**documented information to be retained**//​. ​ \\ <wrap em>​**[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor.]**</​wrap>​ |  8.5.1.2f ​ | |  17  | 8.5.1.2 Validation and Control of Special Processes \\ For processes where the resulting output cannot be verified by subsequent monitoring or measurement,​ the organization shall establish arrangements for these processes including, as applicable: \\ f. requirements for //​**documented information to be retained**//​. ​ \\ <wrap em>​**[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor.]**</​wrap>​ |  8.5.1.2f ​ |
-|  18  | 8.5.1.3 Production Process Verification \\ The organization shall //**retain documented information**//​ on the results of production process verification. |  8.5.1.3 ​ |+|  ​**18**  | 8.5.1.3 Production Process Verification \\ The organization shall //**retain documented information**//​ on the results of production process verification. |  8.5.1.3 ​ |
 |  19  | 8.5.2 Identification and Traceability \\ The organization shall control the unique identification of the outputs when traceability is a requirement,​ and shall //**retain the documented information**//​ __necessary__ to enable traceability. |  8.5.2  | |  19  | 8.5.2 Identification and Traceability \\ The organization shall control the unique identification of the outputs when traceability is a requirement,​ and shall //**retain the documented information**//​ __necessary__ to enable traceability. |  8.5.2  |
 |  20  | 8.5.3 Property Belonging to Customers or External Providers \\ When the property of a customer or external provider is lost, damaged, or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and //**retain documented information**//​ on what has occurred. |  8.5.3  | |  20  | 8.5.3 Property Belonging to Customers or External Providers \\ When the property of a customer or external provider is lost, damaged, or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and //**retain documented information**//​ on what has occurred. |  8.5.3  |
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 |  24  | 9.1 Monitoring, Measurement,​ Analysis, and Evaluation \\ The organization shall evaluate the performance and the effectiveness of the quality management system. \\ The organization shall //**retain appropriate documented information**//​ as evidence of the results. |  9.1.1  | |  24  | 9.1 Monitoring, Measurement,​ Analysis, and Evaluation \\ The organization shall evaluate the performance and the effectiveness of the quality management system. \\ The organization shall //**retain appropriate documented information**//​ as evidence of the results. |  9.1.1  |
 |  25  | 9.2.2 The organization shall: \\ f. //**retain documented information**//​ as evidence of the implementation of the audit program and the audit results. \\ NOTE: See ISO 19011 for guidance. |  9.2.2f ​ | |  25  | 9.2.2 The organization shall: \\ f. //**retain documented information**//​ as evidence of the implementation of the audit program and the audit results. \\ NOTE: See ISO 19011 for guidance. |  9.2.2f ​ |
-|  26  | The organization shall //**retain documented information**//​ as evidence of the results of management reviews. |  9.3.3  | +|  ​**26**  | The organization shall //**retain documented information**//​ as evidence of the results of management reviews. |  9.3.3  | 
-|  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 ​ |
  
  
-<note important>​**#​ 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.</​note>​+<note important>​**#​ 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.</​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>​ <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 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 authorized. Examples of evidence can include stamps, electronic signatures, initials, or names.//</​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 authorized. Examples of evidence can include stamps, electronic signatures, initials, or names.//</​note>​
  
-<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 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 produce, lead-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.+<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 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 produce, lead-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.
 Regarding the "​records"​ we require the organization to retain documented information on how they ensure production process verification is implemented.//"</​note>​ Regarding the "​records"​ we require the organization to retain documented information on how they ensure production process verification is implemented.//"</​note>​