Manufacturing process was not effectively updated process control documents as bellowing discrepancies found during the audit;
The slitting control # WI-N09-QC-0002 REV 01 26-12-2013 was not updated process step as revised internal packing at end of manufacturing line since July, 2015.
The slitting PFMEA # PFMEA-CSM005 rev. 15/1/2013 was not reviewed with the current manufacturing process flow including current score e.g. process flow has been changes since July, 2015, defective tend to high since January, 2015.
Shearing PFMEA #PFMEA-CSM006 rev. 26/8/2013 was not specified special characteristic (SC) whilst the control plan # WI-N09-QC-0003 REV 02 4-09-2014 defined “L” as SC.
In OCT 2014 : Taken action for claim QA-10/016 : PAD mark : M/C no. 1007C83=E11=0 : size 0.8 x0310 over put force : taken action reduce pressure 2 to 1 bar : closed out 12/11/2014 not any review and revised PFMEA