During investigation do not directly conclude the root cause based on your immediate observation. There may be the some other reasons too.
For example, if any failure observed in unknown impurity due to instrument error (pressure fluctuations) . Based on this observation generally investigator consider this as an obvious root cause and missed to rule out other possible reasons like extraneous peak or product contamination.
Force degradation study data is very helpful to rule out and to prove that this failure is not a product issues, or subjected impurity peak due to degradation due to improper sample preparations.
Before saying this failure due to instrument malfunction only we have to rule out all other possible reasons through SYSTEMATIC ROOT CAUSE ANALYSIS (Write all possible reasons of failure and rule out this one by one till final root cause). This is the most recent expectation of auditor.
For example, if any failure observed in unknown impurity due to instrument error (pressure fluctuations) . Based on this observation generally investigator consider this as an obvious root cause and missed to rule out other possible reasons like extraneous peak or product contamination.
Force degradation study data is very helpful to rule out and to prove that this failure is not a product issues, or subjected impurity peak due to degradation due to improper sample preparations.
Before saying this failure due to instrument malfunction only we have to rule out all other possible reasons through SYSTEMATIC ROOT CAUSE ANALYSIS (Write all possible reasons of failure and rule out this one by one till final root cause). This is the most recent expectation of auditor.
In the case of instrument malfunction also evaluate and investigate all impurities.
ReplyDeleteHypothesis from same preparation to be performed and it will be avident that the failure is not due to extraneous interference, but due to malfunction.
Moreover find out the exact reason for malfunction and it's impact on analysis, which can help to derive root cause.