8.Not made FMEA or failure mode of MOUNT 2 part number. Need to create FMEA of Mount 2 part number.
9.Have online judgment meeting but not have record in meeting for judge status before start mass production.
(Create format to judge)
10.No have flow chart to submit KENTEI. Need to create flow both of CHUGAI and HIKIFUNE.
III Production process
12. Add PV/PI standard in WI and refer number of limit sample in inspection WI.
13. Confirm EXP date every chemical in W/H chemical , EX : GIDAON.
Review method for record temperature and humidity.
Inventory check for monitoring EXP date and balance about slow move.
14. Not calibrate pin gauge and screw gauge. Add plan calibration.
15. Revise WI inspection (HTL-Q0001)
IV Quality Preservation &Reinforcement
19.No have internal audit , Need to create plan to internal audit.
20.No have log file to register number of limit sample and limit in process not run number.
21.No have improvement plan. Need to record in process defect and make plan to improvement
(preventive action) HIKIFUNE need to make PDCA.
22.Need to review method to test cross cut follow to STT standard and tape for test of cross cut need to
keep it.