Root cause And How we can proceed CAPA and supportive documentation. Please reply i have interview tomorrow

Quality Assurance
1

Hi, please give me examples how we can do root cause analysis ? And How we can proceed CAPA and supportive documentation. Please reply i have interview tomorrow
Thanks

2

Root cause means the complete back history for that one particular problem about which you have received complain or any non conformance.
CAPA is taken to prevent recurrence such type of problem.

3

Hi @Ravi.yadav770 could you explain more please
Thanks

4

Root cause is the main / probable cause for any failure or deviation which is derived from the complete investigation based on why why type or ishikawa fishbone diagram or any other tools.

for CAPA, CA is the corrective action taken for any failure during deviation or any OOS
PA is the preventive action to stop the reoccurring the same failure in future.

For example, if one of your batch failed in complete analysis in water content then OOS is logged for the same.
Hence, based on OOS Phase-I investigation is done by QC department to confirmed the failure as per systemic procedure.
If no root cause has been identified then Phase-II investigation (Plant investigation) needs to be done to find out the exact root cause for failure by following various investigation tools.
After finding the exact root cause for failure of water content, corrective action needs to be decided for that batch to proceed further.
Based on root cause to prevent the failure in future, preventive action needs to be established and continuous monitoring shall be done for effectiveness of CAPA proposed.

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5

You can use different investigation tools based on the incident/ deviation/ complaint. Select the tool appropriate and eliminate probable causes to trace actual root cause. Tools like 5why, FBA, FTA are commonly used. FMEA is used to identify probable causes at each stage of manufacturing. Coming to examples, use your own. Do not quote incidents from your present work place in interview or any symposium. Wishes.

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Root cause is identified error of any failure by investigation and CAPA is the immediate action taken to rectify error and action taken to prevent to avoid that same types of error

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