if deviation will occured in the production then 1st we should raise the deviation with in 24 hpurs and that deviation form (if sap) shall be submitted to QA and after that what are the steps can any one help me out…
Firstly you need to investigate that deviation in that you have to mention details about the incident , personal involved , and it’s impact. Then after identifying its impact u have to decide whether it minor or major by discussing with the QA. Then if it’s majar deviation raise the capa for it and if it’s minor then take action accordingly like retraining of the person if it’s happen due to human error.
When deviation occurred in the process or production then immediately inform to concern head and QA people and then raise a deviation form with mentioning complete details of identified deviation. The QA shall analyze the risk with supporting from other departments if required. Based on the risk analysis, deviation shall clasiffied as minor or major. If deviation classified as minor then identify correction (immediate action) and rectify and the same documented. There is no need strong investigation for minor deviations.
If deviation is major/critical then immediately identify the root cause with strong scientific justification then proposed a effective CAPA procedure to rectify the deviation and implement the CAPA procedure within the timeline without fail. the details of deviation shall be recorded in respective process BMR and all supportive documents of deviation shall be forwarded to QA for successful deviation closure.
Don’t forget to investigate any impact on previous or future batches