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!rowspan="4"|Manufacturing Documents
| Manufacturing procedures, component specifications, raw material specifications, in-coming incoming and in-process inspection procedures for completeness|
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# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures
# Correlate incoming and in-process inspection procedures with the process specifications
| Material science, manufacturing engineering, quality systems
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| Linkage between component and raw material specifications and appropriate incoming inspection procedures
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# |Material science, quality systems
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| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials
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# Review supplier audit reports for compliance|Manufacturing engineering, quality systems
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| calibration Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations
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