ČSN EN 9102 (310404)

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Anotace textu normy ČSN EN 9102 (310404):

This document establishes the requirements for performing and documenting FAI. It is emphasized the requirements specified in this document are complementary (not alternative) to customer and applicable statutory and regulatory requirements.

The primary purpose of FAI is to verify and validate product realization processes are capable of producing characteristics that meet engineering and design requirements. 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 A FAI is not a product acceptance document. While interrelated, FAI and product acceptance are separate activities. The focus of FAI 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 product is nonconforming to engineering and design requirements.

FAI will:

• - provide confidence, through objective evidence, the product realization processes are capable of producing conforming product;
• - demonstrate the manufacturers and processors of the product have an understanding of the associated requirements;
• - provide assurance of product conformance at the start of production and after changes, as outlined in this document.

A FAI is intended to:

• - mitigate risks associated with production startup and process changes;
• - reduce future escapes;
• - 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 characteristics and initiate and/or validate associated corrective actions.

This document applies to organizations and their suppliers 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 also applies to suppliers performing special process(es). A certificate of conformance (CoC) provided by processors attests to satisfying the requirements. External suppliers providing special process(es) can satisfy this document´s requirements by either:

• - documenting the design characteristics and associated results on a first article inspection report (FAIR); or
• - documenting the design characteristics and associated results on a detailed CoC.

This document applies to assemblies, sub-assemblies, and detail parts including castings, forgings, and modifications to standard catalogue or commercial-off-the-shelf (COTS) items. Each of these items have a separate 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 item, COTS, or deliverable software. When these items are included in an assembly, they shall be documented in the index of part numbers in an assembly FAIR