Secondary packing line
There is continuous rejection after carton closure.
Line officer, QA officer , operator on line, suddenly any auditor came along with plant head, QA head, QA incharge on above mentioned packing line. Then?
QA officer is remain silence in front of his manager and auditor AND thought manager will take some action, manager also silent. And continuous rejection going on…
Who should stop the line?
If plant head later replied as auditor was unaware about this thing, why u stopped.
It is not a hard and fast rule that only QA has to interven and stop the non-conformances happening arround. It is the duty and responsibility of every employee working in pharma indusry to produce quality products. Only QA is not responsible for quality. Whosoever notices the problem or any non-conformance or deviation must bring to the notice of his or her supervisor immediately, it can be an operator, suoervisor, Manager, or QA person. After verifying the situation / non-conformance appropriate actions should be taken and should be resolved at the earliest. This can be done either by stopping the packing line or withheld processing untill the issue is resolved. Fill up deviation form as per SOP, investigate in to the matter, resolve the issue, get fresh Line clearance from QA and restart the activity. Please remember that,
“Quality is everybodies responsibility”