Critical Mistakes during Root Cause Investigation
🔴 Critical Mistakes in Root Cause Investigation (RCI):
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Jumping to Conclusions – Assuming the cause without evidence or proper investigation.
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Superficial Investigation – Stopping at symptoms instead of identifying the true underlying cause.
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Poor Documentation – Incomplete or unclear investigation records that cannot stand regulatory scrutiny.
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Bias in Investigation – Blaming individuals instead of analyzing process, system, or training gaps.
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Ignoring Data & Trends – Not reviewing past deviations, OOS/OOT, or audit findings that indicate recurring issues.
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Inadequate Use of Tools – Not applying structured tools like Fishbone, 5 Whys, or FMEA effectively.
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Failure to Involve SMEs – Excluding subject matter experts, leading to incomplete problem analysis.
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Overlooking Human Factors – Not considering training gaps, fatigue, workload, or behavioral aspects.
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Weak CAPA Linkage – Corrective and preventive actions not directly addressing the identified root cause.
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Not Verifying Effectiveness – Skipping follow-up to check if CAPA truly resolved the issue.
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Time Pressure & Compliance Mindset – Rushing to close the investigation just to meet timelines, rather than ensuring accuracy.
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Lack of Cross-functional Review – Not engaging QA, QC, production, and engineering teams for holistic evaluation.
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