More often than not, operator error is the root cause for a deviation and retraining is the corrective action. What’s wrong with using operator error as the root cause? Actually, a lot of unwanted consequences.
Conducting an analysis using 4Ms: man, machine, methods, and materials, enables deviation investigators to conduct a true root cause.
- 4 Ms Fish Bone (Cause and Effect) Diagram for Training RCA
- Suggestions on how to proceed when the error is NOT a training issue
- 4 Possible actions to pursue as Corrective Actions
Additional List of Resources
Who Likes this Article:
This article appeals to a wide audience within Quality Assurance and Regulatory Affairs.
- Compliance Trainers love to use this article to help explain why repeated use of Operator Error sends the wrong messages to Regulatory Agencies.
- Root Cause Analysis teams refer to the fishbone diagram to frame the training questions to ask when investigating a failed training transfer event.
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