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| articles:as9100d_oe_requirements-2 [2020/10/19 18:35] – 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>**[While this requirement is SUBJECTIVE, the Accreditation Body auditors have interpreted this to mean that EVERYWHERE the standard uses the word "PLAN", there must be an associated record. This significantly expands the number of records required to include: \\ | | **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: \\ |
| 5.3e (ensuring that the integrity of the quality management system is maintained when changes to the quality management system are implemented) \\ | 7.5.1 General \\ |
| 6.1.2a - actions to address risks and opportunities \\ | The organization’s quality management system shall include: \\ |
| 6.1.2b - evaluations of "the effectiveness" of "actions" taken to address risks and opportunities \\ | • documented information required by this International Standard; \\ |
| 6.2.2 "When planning how to achieve its quality objectives", records must identify: \\ | • documented information DETERMINED BY THE ORGANIZATION as being necessary for the effectiveness of the quality management system. \\ |
| a. what will be done; \\ | \\ |
| b. what resources will be required; \\ | AND Annex A.6 \\ |
| c. who will be responsible; \\ | “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." \\ |
| d. when it will be completed; \\ | \\ |
| e. how the results will be evaluated. \\ | 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.] \\ |
| 6.3 "changes to the quality management system" \\ | **</wrap> | 4.4.2b | |
| 8.1 - Usually demonstrated through a Work Order / Traveler. \\ | | **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 | |
| 8.1e. - "determining, maintaining, and retaining documented information to the extent necessary: 1. to have confidence that the processes have been carried out __as planned__;" \\ | |
| 8.1g. - engagement of representatives of affected organization functions for operational __planning__ and control \\ | |
| 8.1 - "manage product and service provision in a structured and controlled manner including scheduled events performed in a __planned__ sequence to meet requirements at acceptable risk, within resource and schedule constraints." \\ | |
| 8.1 - The organization shall control __planned__ changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary." \\ | |
| 8.1 - "__plan__, implement, and control the temporary or permanent transfer of work, to ensure the continuing conformity of the work to requirements. The process shall ensure that work transfer impacts and risks are managed." \\ | |
| 8.1.1 - "__plan__, implement, and control a process for managing operational risks to the achievement of applicable requirements, which includes as appropriate to the organization and the products and services: \\ | |
| a. assignment of responsibilities for operational risk management; \\ | |
| b. definition of risk assessment criteria (e.g., likelihood, consequences, risk acceptance); \\ | |
| c. identification, assessment, and communication of risks throughout operations; \\ | |
| d. identification, implementation, and management of actions to mitigate risks that exceed the defined risk acceptance criteria; \\ | |
| e. acceptance of risks remaining after implementation of mitigating actions." \\ | |
| 8.1.2 - "__plan__, implement, and control a process for configuration management as appropriate to the organization and its products and services in order to ensure the identification and control of physical and functional attributes throughout the product lifecycle. This process shall: \\ | |
| a. control product identity and traceability to requirements, including the implementation of identified changes; \\ | |
| b. ensure that the documented information (e.g., requirements, design, verification, validation and acceptance documentation) is consistent with the actual attributes of the products and services." \\ | |
| 8.1.3 - "__plan__, implement, and control the processes needed to assure product safety during the entire product life cycle, as appropriate to the organization and the product." \\ | |
| 8.1.4 - "__plan__, implement, and control processes, appropriate to the organization and the product, for the prevention of counterfeit or suspect counterfeit part use and their inclusion in product(s) delivered to the customer." \\ | |
| 8.3.4.1 - "When tests are necessary for verification and validation, these tests shall be planned, controlled, reviewed, and documented to ensure and prove the following: \\ | |
| a. test plans or specifications identify the test item being tested and the resources being used, define test objectives and conditions, parameters to be recorded and relevant acceptance criteria; \\ | |
| b. test procedures describe the test methods to be used, how to perform the test, and how to record the results; \\ | |
| c. the correct configuration of the test item is submitted for the test; \\ | |
| d. the requirements of the test plan and the test procedures are observed; \\ | |
| e. the acceptance criteria are met." \\ | |
| 8.5.1 - "when sampling is used as a means of product acceptance, the sampling plan is justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan to the criticality of the product and to the process capability)." \\ | |
| | |
| ]**</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 | | |
| | **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 | |
