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Brief introduction of the methodology of a RCA process, a detailed course outline and training deliverables:

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Introduction

In simple terms, a common problem solving process has four major parts:

-Grasp the situation
-Cause Investigation
-Problem Correction
-Prevention through Errorproofing

During the first part (Grasp the Situation) of the process, we:

-Identify the problem
-Clarify the problem
-Locate the point of Cause (PoC)

In the second part (Cause Investigation), we use several methods including:

Conducting a “5-Why” investigation to identify the root cause
(for the specific problem, for the lack of detection, for system failures)

In the third part (Problem Correction) of the process, we take specific action to correct the problem. At a minimum, short-term temporary measures are required to protect the customer followed by longer term corrective action.

In the fourth part (Prevention) of the process, take specific action to make sure the problem cannot recur, typically through errorproofing and capturing the lessons
learned.

Root Cause Analysis Outline

After this course participants will be able to:

-Respond effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions
-Determine whether or not a complaint should go through a CAPA program
-Perform trend analysis and use effective RCA tools (5 Why’s, Flow Charting, Fault Tree Analysis, Fishbone Diagrams, etc.)
-Verify and validate a CAPA/RCA process corrective actions
-Integrate RCA with other systems: internal auditing, CAPA and complaint handling
-Gather, organize and manage the data required to conduct RCA
-Optimize CAPA and RCA documentation procedures

PROPLEM SOLVING APPROACH

1. Problem Statement

In a simple sentence, identify the object and the unsatisfactory condition (what is wrong with what?). For example, speaker frame is scratched, capacitor lead is broken, et cetera. Ask why the unsatisfactory condition exists and repeat this question until you cannot answer it with certainty (why is the speaker frame scratched?). At this point, revise the problem statement.

2. Interim Action/Containment

Identify the temporary action that will prevent the complainant from experiencing the problem. This is the action that keeps the customer from receiving additional defects or poor service. Document any criteria, collect any data, identify important dates, and verify and validate the action(s).

3. Problem Definition and Analysis of Root Cause

The problem definition is a list of all relevant facts or simply a fact list.
Analysis of root cause is the act of breaking down a large problem into its fundamental elements. These fundamental elements are potential causes. Common analysis methods include brainstorming and “Why” analysis.

4. Define Root Cause and Escape Point

The root cause is the single verified reason that accounts for the problem. Test each potential cause to arrive at the single root cause. The escape point is the earliest location in a process where the occurrence of the problem should have been detected, but was not.

5. Choose and Verify Corrective Action

Brainstorm potential corrective actions and select the corrective action that fixes the problem at the root cause level, generates no additional problems, and has been verified to work. Also, address any failure to detect the problem.

6. Implement and Validate Corrective Action

Develop a detailed implementation plan that includes what will be done, where it will be done, when it will be done, who will do it, and how it will be done. Validate the corrective action by evaluating the performance results over time (validation confirms that the corrective action is effective).

7. Prevent Recurrence

Prevent recurrence by including the corrective action and lessons learned into the management systems, operating systems, and procedures. Make any necessary documentation changes to drawings, bills of material, control plans, et cetera.



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