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AS9100 Rev D: Risks, Configuration and FAI
1. Is Risk assessment during implementation of QMS (6.1) & Risk management of Operational risks (8.1.1) is to be maintained as a mandatory documented information?
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Mark Hammar
May 15, 2018
2. Is Configuration audit to be done for Products & services?
3. If "No" for the 2nd query,whether Configuration audit to be done only during New Product/Production part introduction?
4. Does the Standard emphasise on Last Piece Inspection?
Answer:
1) In both clause 6.1 and 8.1.1 there is no requirement for documented information, however, as there is a need in both cases to review this risk listing and the action taken to address risks it is very common that these activities will need to be documented in order to facilitate these reviews.
2) Configuration management (8.1.2) is applicable to both products and services, but as is indicated it is to be implemented “as appropriate” to the organization. So if your services do not require a configuration management system per your customer requirements then this is not necessary.
3) Configuration management is applicable to all productions, as you can see in 8.1.2b it includes an assurance that the documents for the product are consistent with he actual attributes. In other words, the configuration of the actual product or service meets the configured requirements for that product or service.
4) The standard does not emphasize last piece inspection, but rather emphasizes “production process verification” (clause 8.5.1.3) which includes taking a representative item form the first production run to validate that all processes are working, which is also know as First Article Inspection.
3. If "No" for the 2nd query,whether Configuration audit to be done only during New Product/Production part introduction?
4. Does the Standard emphasise on Last Piece Inspection?
Answer:
1) In both clause 6.1 and 8.1.1 there is no requirement for documented information, however, as there is a need in both cases to review this risk listing and the action taken to address risks it is very common that these activities will need to be documented in order to facilitate these reviews.
2) Configuration management (8.1.2) is applicable to both products and services, but as is indicated it is to be implemented “as appropriate” to the organization. So if your services do not require a configuration management system per your customer requirements then this is not necessary.
3) Configuration management is applicable to all productions, as you can see in 8.1.2b it includes an assurance that the documents for the product are consistent with he actual attributes. In other words, the configuration of the actual product or service meets the configured requirements for that product or service.
4) The standard does not emphasize last piece inspection, but rather emphasizes “production process verification” (clause 8.5.1.3) which includes taking a representative item form the first production run to validate that all processes are working, which is also know as First Article Inspection.
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May 15, 2018
May 15, 2018
May 15, 2018