Hi,
i want to ask about the categorization of Handling of deviation and failure in general ( Major, minor and the critical category), can you give me some examples about what the major categories or minor and critical categories?. and what method should i take to investigate the deviation & failure( is Ishikawa method or fault tree analysis) or is there other method?
thank you
Hi,
The unplanned deviations or non-conformaces can be categorized as Quality impacting or Quality Non Impacting or as as Critical measure minor based on the extent of affect on the product quality.
e.g. The two differnt products stored adjacent to each other during processing leading to chance of mix up and thus it beaomes a Quality Impacting or Ctitical deviation.
You can find examples of your own when you evalaute each procedure or situation.
For investigation you can choose any investigational tool through whichyou will able to find the root casue of a deviation.
But more importantaly while concluding the investigation you should able to decide the appropriate CAPA and that needs to be monitored.
Regards
Ganesh
dear ganesh,
what if i categorize the deviation in Major and Minor failure. Major failure for the failure that impact to the product, and the minor failure not impact to the product. or should i categorize it with three (Major, Minor and critical failure)? im still confuse with the categorize.
can you give me example of form Deviation and Corrective action prefer to GMP?
thank you
Rika
Is it Required to Generate a CAPA for a Single Failuare??? If yes then why the Deviation cant be closed on Investigations & the subsequent Corrective actions?? Since deviations raised may be of different reasons & it is not possible to raise the CAPA for each deviation.Can you please explain after how many devaitions of same nature shall lead to Generation of CAPA & Why?
Dear Vinod
See my ans in blue
Is it Required to Generate a CAPA for a Single Failuare???
NO
If yes then why the Deviation cant be closed on Investigations & the subsequent Corrective actions??
Deviation can be closed
Since deviations raised may be of different reasons & it is not possible to raise the CAPA for each deviation.Can you please explain after how many devaitions of same nature shall lead to Generation of CAPA & Why?
[COLOR=“Blue”]Same deviation is occuring and reocurring then it will trigger CAPA.
Nowhere it has been stated that how deviations should trigger CAPA.
It is upto us to take early CAPA and work on it which will ultmately meet our quality objectives.[/color]
Warm Regards
Ravindra Upare.
Can you explain how to initiate the CAPA.& What are the ways to close the CAPA