Changes

# Review manufacturing procedures, component specifications, raw material specifications, in-coming and in-process inspection procedures for completeness. # Review linkage between component and raw material specifications and appropriate in-coming inspection procedures. # Ensure inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials. # Review of calibration records and preventive maintenance records would be also performed. This would also include a review of the in-process / incoming inspection test methods and related test method validations.