A #So, your data send to me for item 1/4 NC validation. I need you to amend report as below. If not correct, please amend its.
Cause :- 1) Unclear for validation protocol cause from less skill for validation program.
2) WI have not “Machine parameter setting” so, operator cannot put condition in protocol.
3) QC had no check validation protocol before sampling test.
Correction :- 1) Inform all concern (QC/TQE) to know this problem and train them to pay attention check protocol before testing.
Corrective action :- 1) To revise OQ protocol à adding validation condition and clear for sample for testing by specific test quantity / item. Finished within ………..