Give me One best Example For difference Incident, deviation and capa Example need compare to QC.
Incident means departed from the approved standard testing / operating procedure, which is not having impact on the quality of the product.
Ex: In QC, product batch number unintentionally wrong entered during the analysis…
Deviation means departed from the approved standard testing / operating procedure which have impact on the quality of the product.
Ex. During the analysis, not followed the STP of the particular product, which may leads to impact on the reporting results…
CAPA-For C.A follow the respective STP in repeat analysis by the same analyst including duplicate analysis…
P.A- Training to be imparted to the concerned personnel on GTP or on particular STP.
Incident means unplanned
Deviations is the planned one
Incidence: Any undesired results or failure which does not have any imapact on the quality or patient safety and product efficacy
Deviation are of two types i. e. Planned deviation and Unplanned deviation.
Planned Deviations are those which is done deliberately to make any changes, planned deviation is done via raising the change control and assessing the risk first e.g. During the validation of Analytical method we perform the robustness parameter in that we deliberately change the chromatographic parameters i.e. Flow rate change from 1.0ml to 1.2 ml to check its impact on the results, it could be either on passing side or towards failing side.
Unplanned Deviation: Any unplanned occurrence, or desired event which represents departure from the approved standard procedure e.g. Analytical balance is having operating range of 20 mg to 200 g i. e. Balance is suitable to weigh between this range, buy sample weight was taken below to the 20mg i. e. Below operating range, this is called unplanned deviation due to human error.
Corrective Action: It is the action which is to be taken to avoid the reoccurrence of the identified discrepancy. e.g. Sample was re prepared using another balance which covers the 20 mg weight of the sample. Balance with operating range from 2 mg to 50g.
Preventative action : Any action which is to be take to avoid the occurrence of the potention impact of the identified diecrepancy in the future. e.g. Affix a Label that mentions operating range of weighing balance on its display so that analyst can easily ensure the operating range or mention operating range of balance on weight print so that before preparation analyst can easily identify that weight was not taken within the range, so the weighing can be discarded with appropriate justification.