Good afternoon to all of you,
Actually we have one reactor having two propeller i.e. upper propeller and lower propeller. Previously we modify the stirrer by shifting upper propeller to the downward position for execution of one new product. We manufactured that product by shifting upper propeller to the downward position. After completion of project, we manufactured another product in same reactor which was manufactured previously in same reactor. But after changing of propeller position, same was reported as OOS. During investigation, root cause is the modification work of stirrer which is lead to fail the product. previously we failed to initiate the change control for modification work. Now we initiated one deviation for the same.
Now I have to prepare impact assessment report. So what contain I include in impact assessment report.?