Course Name
Effective Root Cause Analysis (RCA) Workshop
Course Overview
Welcome to the Effective Root Cause Analysis (RCA) Workshop by ARG Academy. This two-day practical training program provides a structured, hands-on understanding of Root Cause Analysis specifically tailored for the medical device manufacturing industry. The course focuses on identifying true root causes rather than just addressing symptoms using systematic problem-solving tools. Participants will explore real-case scenarios relevant to medical device production, including molding, packaging, visual inspection, and sterile product manufacturing, ensuring the training is highly applicable to your daily operations.
Course Objective
This course aims to equip participants with the skills to align their problem-solving processes with regulatory expectations, such as ISO 13485:2016 and FDA QSR concepts. By the end of this training, participants will be able to:
● Clearly define the differences between symptoms, direct causes, contributing factors, and root causes.
● Differentiate between correction, corrective action, and preventive action.
● Apply structured RCA methodologies, including the 5 Whys, Fishbone (Ishikawa) Diagram, Is/Is Not analysis, Pareto Chart, and basic FMEA.
● Identify physical, human, and organizational causes while avoiding common RCA mistakes.
● Develop effective corrective actions and establish verifiable effectiveness checks.
● Promote a “no-blame” investigation culture that supports regulatory compliance and patient safety.
Course Benefits
Participating in this workshop provides several key organizational and professional advantages:
● Data-Driven Decision Making: Learn to replace assumptions with data-driven analysis to reach sustainable solutions.
● Patient Safety & Compliance: Align your investigation processes with critical regulatory expectations to better ensure patient safety.
● Sustainable Improvements: Develop the skills necessary to implement CAPA (Corrective and Preventive Action) effectively, preventing the recurrence of manufacturing issues.
● Cultural Growth: Gain tools to move your organization toward a “no-blame” investigation culture, fostering better cross-functional teamwork.
Who Must Attend
This workshop is designed for professionals and teams involved in maintaining quality and improving processes within manufacturing operations, including:
● QA/QC personnel
● Production supervisors
● Engineers and process improvement teams
● Staff involved in nonconformance handling, CAPA, and complaint investigations
Note: Participants should have a basic knowledge of manufacturing processes and quality concepts, with experience in problem-solving activities.
Methodology
The training uses a highly interactive, hands-on approach:
● Interactive Learning: The course utilizes lectures, group discussions, and practical examples to build foundational knowledge.
● Practical Workshops: The core of the program is built around five practical workshops:
– Workshop A (Icebreaker): Focusing on teamwork and problem-solving.
– Workshop B (5 Whys): Applying analysis to a molding parameter failure scenario.
– Workshop C (Fishbone): Practicing brainstorming on packaging or equipment failures.
– Workshop D (Pareto): Analyzing visual inspection defect datasets.
– Workshop E (CAPA Practical): Distinguishing between correction and corrective action.
● Evaluation: Understanding is assessed through workshop outputs, practical tool application, and an optional end-of-course quiz.
Course Duration
● The training is conducted over 2 days.
● The typical daily schedule runs from 09:00 to 17:00 (14 hours total).
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