4.3 Audits and capability verification

Audit Program Standard

Audit types (initial, periodic, triggered, remote), frequency by risk, required outputs (findings, corrective actions, verification plan). Defines “major/minor/systemic”.

Process Audit Checklist (Electronics)

SQ checklist focusing on defect mechanisms: ESD, MSL, storage, traceability, calibration, soldering profile control, cleanliness/ionic, programming control, inspection/test coverage, rework discipline.

Special Process Validation Requirements

For any special process at supplier: reflow/wave/selective, coating/potting, press-fit, crimping, welding, cleaning, test. Required evidence: validation record, control limits, periodic revalidation.