1. Purpose and scope
A released document set is a promise; this stage is where the organisation keeps it. Every process now runs as described, and in doing so produces the records that show it works. An auditor, internal or external, will judge the system mostly by sampling these records and by watching the work, so the aim is not to create paperwork for audit but to make the normal output of each process good enough to serve as evidence.
Several support processes carry most of the weight. Competence and training make sure the people in roles that affect quality can do the work, including operators qualified for specific operations and engineers trained in the core tools. Calibration and measurement systems analysis make sure the measurements used to accept product can be trusted. Supplier approval and monitoring make sure purchased materials, wafers, packages and services meet requirements, with customer requirements flowed down. Control plans, statistical process control and the handling of nonconforming product keep production under control.
Records need time to accumulate. A process that has run for a short period may not yet show trends, reaction to signals, or the full cycle of a periodic activity. The implementation plan should allow each process to run long enough that the internal audit programme can sample a representative set of records.
Out of scope: the planned internal audits themselves, which belong to Internal Audits, although process owners should already be checking their own processes against their descriptions.
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