7.3.3.2 Manufacturing process design output

7.3.3.2  Manufacturing process design output

The manufacturing process design output shall be expressed in terms that can be verified against manufacturing

process design input requirements and validated. The manufacturing process design output shall include

-   specifications and drawings,

-   manufacturing process flow chart/layout,

-   manufacturing process FMEAs,

-   control plan (see 7.5.1.1),

-   work instructions,

-   process approval acceptance criteria,

-   data for quality, reliability, maintainability and measurability,

-   results of error-proofing activities, as appropriate, and

-   methods of rapid detection and feedback of product/manufacturing process nonconformities.