Masterclass on 8D, Root Cause Analysis (RCA) & CAPA

Name: Masterclass on 8D, Root Cause Analysis (RCA) & CAPA
Rating: 4.2 (169 reviews)

Be An Expert on CAPA systems, Root Cause Analysis (RCA), 8D Problem Solving, Continuous Improvement & Lean Six Sigma.

Last updated 6/2024

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What you'll learn

Be an expert in CAPA and 8D problem solving system and work as an Engineer/Manager in any regulated industry.
Create (from scratch) Root Cause Analysis (RCA) tools like Ishikawa Chart, Five Whys, Fault Tree Analysis (FTA), Process Maps, Pareto Chart etc.
Champion continuous improvement tools such as DMAIC, PDCA Cycle & 8D Methodology which is essential knowledge for lean six sigma white or yellow belt exams.
Having an in-depth understanding on aforementioned areas of quality management system is essential for any quality control or quality engineer to possess.
Learn about different lean six sigma tools, continuous improvement tools and how it is connected to CAPA system and 8D problem solving process.
Learn how CAPA system or 8D problem solving is important for Good Manufacturing Practices (GMP).

8 sections • 32 lectures • 3h 6m total length

Introduction3:57
Explore eight disciplines of problem solving, root cause analysis, and corrective and preventive actions using tools like Ishikawa diagrams, DMAIC, PDCA, and Pareto charts for copper systems and other sectors.
Introduction to CAPA4:32
Non-conformances VS CAPA - Similarities and difference5:48
Compare non-conformances and capa, highlighting similarities in addressing product or process issues and root causes, and distinguish when to open non-conformance versus a capa investigation with multiple subject matter experts.

Steps under Corrective Action and Preventative Actions8:17
8D Problem Solving vs CAPA9:00
Compare eight disciplines of problem solving with CAPA and Kappa, highlighting similarities and differences. Highlight that CAPA emphasizes documentation and post-implementation checks to ensure lasting effectiveness.
Regulatory Requirement for CAPA system7:06
CAPA Process Steps7:45
Learn in depth about the process that are needed to be implemented in order to have a successful CAPA

Problem Identification Overview3:19
Identify the problem as a step in 8D by gathering information on what, where, when, and how much, interviewing frontline workers, and crafting a problem description and statement for CAPA.
Problem Description & Statement8:11
Write Problem Statement and Description from Scratch!10:11
Craft a robust problem description and problem statement from scratch using the five w's and one h, detailing who, what, where, when, why, and the impact of a late shipment.

Overview of Qualitative Root Cause Investigations5:33
Five Whys (or 5 Whys) Techniques6:00
Learn how to create Fishbone diagram from Scratch!7:38
Create Fault Tree Analysis (FTA) from Scratch!8:21
Create fault tree analysis (FTA) from scratch to map top-down system level failures, identify primary and secondary causes, and apply logic gates and event symbols to trace root causes.
8D Problem Solving3:35
DMAIC (Lean Six Sigma Tool for continuous improvement)5:19
Master the dmaic strategy for continuous improvement in lean six sigma, defining problems, measuring with pareto charts, analyzing data, applying design of experiments, and sustaining with control charts and fmea.
PDCA Cycle (Lean six sigma tool for continuous improvement)3:08
Process Maps6:35
Learn what process maps are, how it can be used to find root cause of CAPA problem and review and process map to understand how it looks.

Risk Assessment6:51
Explore risk assessment within the RCA and CAPA process, aligning actions with risk management to evaluate severity, probability, and impact using complaints data, and update risk files.
Narrowing down the root causes6:40
Explore the difference between root cause investigation and analysis, and learn to narrow from many causes to two through testing and design of experiments.
Root Cause Statement6:23
Develop a precise root cause statement that links the confirmed cause to the problem with a clear cause and effect relationship, enabling a specific and effective CAPA solution.

Implementation Phase3:20
Implement CAPA solutions after root cause analysis by executing a documented implementation plan, verifying effectiveness, and updating risk management with new controls and work instructions.
Implementation Plan1:48
Creating Action Item for Solution implementation3:37
Action Item Completion Verification4:01
Verification of effective of CAPA4:51
Assess capa effectiveness by collecting data after implementation, comparing six months of pre-implementation data with six months of post-implementation data to confirm improvements and close capa when failures drop.
CAPA Closure6:15

Corrective and Preventative Action (CAPA) and/or 8D problem solving are the systems that is widely used in Medical and Pharmaceutical Industry.
This course aims to teach you everything there is to know about CAPA system & 8D problem solving and how to create CAPA file from Scratch!
Apart from that you will also learn about various lean six sigma and continuous improvement tools such as DMAIC, PDCA cycle etc. which will help one to acquire a Lean six sigma white or yellow belt.
Whether you are getting ready to appear in an interview or are looking to get a promotion to a CAPA or continuous improvement engineer or manager, this course will help you get there.
You will learn in depth of each of the steps to create a successful CAPA.
You will also learn how to create various root cause analysis (RCA) tool such as Fish bone diagram, Pareto Chart, Five whys, process maps, fault tree analysis which will set you apart from rest of your colleagues.
You will learn the difference between CAPA and Non conformance and understand when to use one or the other based on the level of risk each failures possess.
Buying this course means you will have lifetime access to the material in it so you will be able to revisit any of these section at any time.

Professional looking to get into Pharma industry or wanting to be promoted as Quality Engineer or Manager.