This part and process audit template helps assess supplier and manufacturing quality end to end. It covers internal audits, training, preventive maintenance, change control, product testing, NCR handling, regulatory compliance, technical documentation, claims management, and problem solving methods such as 8D and 5 Whys. Evaluate traceability, process flow diagrams, control plans, APQP and PPAP readiness, FMEA quality and updates, SPC and capability studies, and continuous improvement. Review purchasing and sub-supplier approval, goods-in inspections, SOPs, storage and segregation of nonconforming items, record retention, and inbound controls. In production, check startup procedures, instructions at point of use, identification and handling of materials, master samples, calibration, packaging effectiveness, inspection frequency, and alignment with the control plan. Include warehousing checks for inventory monitoring, stock rotation, perishable validity, and labeling to prevent mix-ups.
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