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.?
In principle, impact assessment is carried out before execution of any change to assess it’s impact on the quality of products or quality system. Now since, you have already gone ahead without Change approval and without performing impact assessment, you should investigate in to the matter. Your investigation should include following aspects,
Reason for not following Change control system.
Whyd the reactor was not re-qualified after making this major change?
Why process optimization was not carried out after making a change in the reactor?
Why R&Dwas not involved in the entire process?
Why did in process checks not performed during processing of this product which could have saved this product. You would have got satisfactory product like the other product done on same Reactor.
Any other reasons of failure of this product?
Through investigation must be done and then CAPA should be identified and strictly followed. Also, what about failed batch of this product? How will you salvage this? It is a part of CAPA.