prEN 9102

1.1 This document establishes the requirements for performing and documenting FAI. It is emphasized that the requirements specified in this document are complementary (not alternative) to customer and applicable statutory and regulatory requirements. If there is a conflict between the requirements of this document, and customer or applicable statutory/regulatory requirements, the latter takes precedence. In this document, the following verbal forms are used: - "shall" indicates a requirement; - "should" indicates a recommendation; - "may" indicates a permission; - "can" indicates a possibility or a capability. Information marked as "NOTE" is for guidance in understanding or clarifying the associated requirement. 1.2 Purpose The primary purpose of FAI is to verify and validate product realization processes capable of producing characteristics that meet engineering and design requirements. A FAI is not a product acceptance document. A well-planned and executed FAI by a multi-disciplinary team (e.g., members from responsible functions) provides objective evidence the manufacturer’s processes can produce compliant product, having effectively understood and incorporated the associated requirements. NOTE While interrelated, FAI and product acceptance are separate activities. FAI focus is verification of production processes via assessment of product. FAI and supporting documentation do not provide assurance regarding conformance for product acceptance purposes; neither does the lack of a FAI necessarily imply that the product is nonconforming to engineering and design requirements. FAI will: - provide confidence that the product realization processes are capable of producing conforming product; - demonstrate that the manufacturers and processors of the product have an understanding of the associated requirements; - provide objective evidence of process capability; - mitigate risk associated with production startup and/or process changes; - provide assurance of product conformance at the start of production and after changes, as outlined in this document. A FAI is intended to: - reduce future escapes, risks, and total costs; - help ensure product safety; - improve quality, delivery, and customer satisfaction; - reduce costs and production delays associated with product nonconformances; - identify product realization processes not capable of producing conforming product, and initiate and/or validate associated corrective actions. 1.3 Application This document applies to organizations and sub-tiers responsible for product realization processes that produce the design characteristics of the product. The organization shall flow down the requirements of this document to suppliers who produce design characteristics. This document applies to external suppliers performing special processes. A Certificate of Conformity (CoC) provided by processors attests to satisfying the specification requirements of the applicable design authority. External suppliers providing special processes can satisfy this document’s requirements by either: - documenting the design characteristics and associated results on a FAI; - documenting the design characteristics and associated results on a customer-defined detailed CoC. This document applies to assemblies, sub-assemblies, and detail parts including castings, forgings, and modifications to document catalogue or Commercial-Off-the-Shelf (COTS) items. Each of these items requires a stand-alone FAI. Unless contractually required, this document does not apply to: - development and prototype parts that are not considered as part of the first production run; - procured standard catalogue items, COTS, or deliverable software. These items shall be documented in the index of part numbers in an assembly First Article Inspection Report (FAIR).