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articles:as9100d_oe_requirements-2 [2019/08/18 18:52]
rrandall
articles:as9100d_oe_requirements-2 [2019/08/18 21:32]
rrandall
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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>​
  
-<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>​**#​ 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.// ​\\ \\ 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 example, OTD 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>​
  
 <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>​ <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>​