greenlantern
Starting to get Involved
As much as I like the 8D process the lack of effectivity check when applying it to CAPA needed a workaround. Typically there is just a verification check after implementation of corrective action during the 8D process.
However, coming from medical device background, I started panicking when I didn't see effectivity check after preventive action. I guess repeated FDA audits focusing on ineffective CAPAs will drill it into you. So I added an additional step 7b for verifying the preventive action actually worked. In my experience, the CAPA plan includes a specified period of time after the preventive action is implemented to revisit the CAPA and gather quantified evidence of it's effectiveness.
This is for a CAPA SOP at a start up I work at. Please let me know if you have any feedback. Thanks!
However, coming from medical device background, I started panicking when I didn't see effectivity check after preventive action. I guess repeated FDA audits focusing on ineffective CAPAs will drill it into you. So I added an additional step 7b for verifying the preventive action actually worked. In my experience, the CAPA plan includes a specified period of time after the preventive action is implemented to revisit the CAPA and gather quantified evidence of it's effectiveness.
This is for a CAPA SOP at a start up I work at. Please let me know if you have any feedback. Thanks!