Hi
During our periodic revalidation process, one of the dimensional measure using manual drop indicator found oos for CPK. The Cpk for that particular dimension check is only part of validation, since the value is within specification requirement the technician who performed the test didn't pay attention on his test accuracy. The same tested samples were retested by a second technician and cpk found conforming.
The root cause identified as "Human Error" but my validation department is not in agreement with this comment on our deviation report, Since the device is very straight forward and simple method no additional modification can be made to improve to reduce the probability of error.
looking for your expert comments /opinion , thank you in advance.
During our periodic revalidation process, one of the dimensional measure using manual drop indicator found oos for CPK. The Cpk for that particular dimension check is only part of validation, since the value is within specification requirement the technician who performed the test didn't pay attention on his test accuracy. The same tested samples were retested by a second technician and cpk found conforming.
The root cause identified as "Human Error" but my validation department is not in agreement with this comment on our deviation report, Since the device is very straight forward and simple method no additional modification can be made to improve to reduce the probability of error.
looking for your expert comments /opinion , thank you in advance.