Do You Know How to Identify Root Cause and How to Close Out Your Investigation?

Getting the Root Cause Analysis (RCA) right is at the soul of the implementation of an effective Corrective and Preventive Action (CAPA) program.

Root Cause Analysis3

Getting the Root Cause Analysis (RCA) right is at the soul of the implementation of an effective Corrective and Preventive Action (CAPA) program. Root Cause Analysis and CAPA are tied to each other intricately. This being the case, it is commonsensical to perform the two functions in tandem with each other applying the principles of risk management. This method makes business sense, as it saves time and cost. This requires companies that want to do an RCA in conjunction with CAPA to have complete knowledge of the principles of CAPA.

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The lack of effectiveness of a company’s RCA is reflected in the inability of the CAPA to fulfill its purpose. An effective Quality Management System is unthinkable without CAPA. In the FDA’s thinking, a Quality System can go awry if effective CAPA is not in place.

So, a CAPA action plan rests on a sound Root Cause Analysis. Any organization that fails to implement this can expect recurring problems and issues. Some of them could turn out to be serious enough to derail their business.

Complete understanding of RCA and CAPA

Root Cause Analysis1

All the learning Areas:

  • Regulatory Expectations for Investigations
  • What is RCA and Typical Problems
  • Investigation Process Overview
  • Skills and Tools of an Effective Investigator
  • (Re) Introduction to Root Cause Analysis (RCA)
  • Principles of root cause analysis
  • Why root cause analysis is difficult
  • Methodology of root cause analysis

STEP 1 – Problem Definition

  • How to ensure that the right problem is being worked on
  • Tools and filters for priority setting
  • Developing a clear and sufficient problem statement (includes practice)

STEP 2 – Understanding the Process

  • How every problem is a process failure
  • How diagrams can set boundaries and define interrelationships
  • Using flowcharts to drill down into the right part of the process (includes practice)

STEP 3 – Identifying Possible Causes

  • Multiple ways to identify possible causes
  • Options for selecting or eliminating causes
  • Logic trees as a cause and effect diagram and other tools for investigations
  • Defining the Deviation
  • Identifying Root Cause
  • Corrective and Preventive Actions (CAPA)
  • What is the CAPA System
  • Definition and regulatory interpretation
  • Identifying and writing of corrective actions
  • Abuses of the CAPA system
  • Discuss robustness and effectiveness review
  • Management of the Investigation
  • Members of the Investigation Team
  • Consulting Case Study Practice – Incident/Events
  • Case Study Practice
  • Interactive Exercises and Discussions.