root cause

[Alexander Pasmay Lema]

Root cause analysis (RCA) after a quality complaint or recall starts with containing the issue (blocking affected batches and assessing impact), followed by data collection (traceability, process parameters, lab results, and raw materials). Then, a structured method like 5 Whys or fishbone anlysis is used to identify the true cause across process, equipment, materials, and human factors. Once confirmed with evidence, CAPA are implemented and their effectiveness is verified through monitoring. Important the key is to identify the <em data-start=”593″ data-end=”610″>real root cause, not just the symptom, to avoid recurrence.

[Dr. Mahmoud Elnakeeb]

Cool!

[Md. Abdul Bari]

Good