I am quite new to the quality world compared to most. However, 4.3
8.5.1.3 Production Process Verification The organization shall implement production process verification activities to ensure the production process is able to produce products that meet requirements. NOTE: These activities can include risk assessments, capacity studies, capability studies, and control plans. Downloaded from SAE International by Sandra Geiger, Monday, September 26, 2016 SAE INTERNATIONAL AS9100™D Page 34 of 54 The organization shall use a representative item from the first production run of a new part or assembly to verify that the production processes, production documentation, and tooling are able to produce parts and assemblies that meet requirements. This activity shall be repeated when changes occur that invalidate the original results (e.g., engineering changes, production process changes, tooling changes). NOTE: This activity can be referred to as First Article Inspection (FAI). The organization shall retain documented information on the results of production process verification.
also from 4.3
(the organization shall )provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
So, the purpose of an FAI is to mitigate the risk of escapees and undesired outputs from a process. This make tons of sense when an organization produces medium to high volume production. However, we are a low production facility (in the sense that our largest production we have done was 7 units over the past 6 months) and as a result, we perform 100% inspection and testing of all product. Hence the only way that we have to identify espcapes is if the design personnel realize that a test activity didn't really test the full functionality of a board, or we run into issues with 1 circuit board talking to another and realize that our test didn't weed out these so we retest all of them.
So whats the purpose of the FAI if you are still doing 100% inspection and testing as the risk we currently run is the same whether we perform a FAI or not.
Someone please sanity check me on this.
8.5.1.3 Production Process Verification The organization shall implement production process verification activities to ensure the production process is able to produce products that meet requirements. NOTE: These activities can include risk assessments, capacity studies, capability studies, and control plans. Downloaded from SAE International by Sandra Geiger, Monday, September 26, 2016 SAE INTERNATIONAL AS9100™D Page 34 of 54 The organization shall use a representative item from the first production run of a new part or assembly to verify that the production processes, production documentation, and tooling are able to produce parts and assemblies that meet requirements. This activity shall be repeated when changes occur that invalidate the original results (e.g., engineering changes, production process changes, tooling changes). NOTE: This activity can be referred to as First Article Inspection (FAI). The organization shall retain documented information on the results of production process verification.
also from 4.3
(the organization shall )provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
So, the purpose of an FAI is to mitigate the risk of escapees and undesired outputs from a process. This make tons of sense when an organization produces medium to high volume production. However, we are a low production facility (in the sense that our largest production we have done was 7 units over the past 6 months) and as a result, we perform 100% inspection and testing of all product. Hence the only way that we have to identify espcapes is if the design personnel realize that a test activity didn't really test the full functionality of a board, or we run into issues with 1 circuit board talking to another and realize that our test didn't weed out these so we retest all of them.
So whats the purpose of the FAI if you are still doing 100% inspection and testing as the risk we currently run is the same whether we perform a FAI or not.
Someone please sanity check me on this.