Good Manufacturing Practices (cGMP) - Intermediate

Root Cause Analysis

The course provides an in-depth look at how to investigate errors and incidents of all kinds, using practical, effective Root Cause Analysis methodologies, such as the 5 Whys and the 6Ms. Investigation team roles and responsibilities and best practices are also discussed to allow teams to conduct effective RCA investigations, draw clear conclusions, and develop targeted corrective actions to prevent reoccurrence.

CEU Credits: 0.1
Course Code: ELM-404
Duration: 30 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.0
Effective Date: 09/17/2024

Curriculum for this course

R is for Root Cause Analysis
The Importance of RCA
When Should Structured RCA be Used?
Risk Classification
Roles
Introduction to RCA Tools
The 5 Whys
The 5 Whys in Action
Your Chance to Ask Why
The 6 Ms
The 6 Ms in Action
6Ms Sorting Activity
Ishikawa/Fishbone Anatomy
Problem Statement
Fishbone Brainstorming
Fishbone Analysis
Final Fishbone Steps
RCA Best Practices
Just The Facts
Test your Knowledge
v1.0 - Course Released on 10/29/2024

Author

Matt Peplowski

Owner & Principal, Biopharm Error Prevention Associates, Inc.

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