Root Cause Analysis and CAPA using 8-D Problem Solving Method


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Errors and defects are a problem in virtually every industry. The goal of defect-free/error-free product or service delivery is the aim of every company. However, in order to eliminate defects or errors permanently, you must use a disciplined approach in order to ensure that the problem does not recur. One of the most widely-used tools is the 8 Disciplines (8D) methodology. 8D requires you to identify and fix the problem immediately (put a bandaid on it) while identifying the Root Cause(s), and take steps to address the problem in the short term as well as in the long term (permanent fix).

In this interactive workshop, you’ll learn how to apply the many tools used to identify possible causes, determine (with data) which is the true root cause (or causes, as there may be some compounding of problems occurring), and how to fix them – permanently.

8D is used by a wide variety of industries – from service to design, manufacturing, and fulfillment. 8D has been used by sales forces, development teams, hourly personnel, and C suite effectively, and is a technique that is easily mastered.

One of the biggest detractors to using the 8D technique is that it does not always address the issue fully. However, after studying the reasons behind this weakness, I’ve developed an additional emphasis to minimize risk and maximize success using the 8D framework. This is the only course that teaches this additional emphasis, and I developed this methodology when I was hired by Motorola to eliminate returns for a particular defect (after previous efforts had seen the defect return). I’ve been teaching this “magic bullet” method ever since.

The course is highly interactive and will require all participants to work through examples in class, allowing you to learn experientially as well as through lecture. Class notes are provided so you can concentrate on what we’re talking about vs. taking copious notes.

In this two-day workshop seminar, you’ll learn how broad-based this technique is, how it can be easily adapted for a wide variety of industries, and how to participate in, and lead, an 8D team.

Learning Objectives:

Upon completing this course participants should be able to:

  • Explain what 8D is and how it is applied
  • Understand where 8D is used in the PDCA cycle
  • Apply various tools and techniques to describe the problem more accurately
  • Understand what is a Root Cause of a problem, vs. what is a symptom of the problem
  • Understand which types and severity of problems should initiate a formal Root Cause Analysis (RCA)
  • Utilize a Risk Based approach to identifying Root Cause Analysis
  • Apply RCA to Context of the Organization and Risk Analysis
  • Evaluate effectiveness of proposed Corrective Actions in addressing the Root Cause
  • Apply various tools to RCA and 8D
  • Understand the difference between short-term/interim solutions and long-term/permanent solutions.
  • Participate in an 8D team
  • Apply various quality tools to determine long-term solutions
  • Lead an 8D team successfully
  • How this fits into the Corrective and Preventive Action (CAPA) program
  • Determine when to stop collecting data/evidence of effectiveness
  • How to use 8D when answering Supplier Corrective Action Requests (SCARs)
  • Apply this to your own organization effectively.

Who Will Benefit:

This course is designed for anyone who is participates in addressing Supplier Corrective Actions, internal corrective action programs, or who is tasked for eliminating or minimizing defects as part of a Continual Improvement (CI) program. This includes those that have Quality, Environmental, or Occupational Health/Safety Management Systems responsibilities for making general improvements in their organization’s performance, as well as the specialists in various areas who are the subject matter experts. A partial list of personnel who will benefit from the course:

  • Senior managers
  • Quality professionals
  • Environmental professionals
  • Occupational Health/Safety (OHS) professionals
  • Regulatory professionals
  • Production supervisors and managers
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Process owners
  • Supplier engineers
  • Customer engineers
  • Quality, environmental, and OHS auditors
  • QMS, EMS, and OHS Management Representatives
Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Brief Background and History
    • What is 8D
    • Who uses 8D / applications in various industries
  • The 8 Disciplines (8D) Overview
    • Review of each step
    • Learn the common tools to use at each step including
      • Is / Is not technique
      • 5 whys
      • Pareto Diagram
      • Fault Tree Analysis
      • Value Stream Mapping / Process Flow charts
      • Paynter Chart
      • Fishbone (Ishikawa / Cause and Effect) Diagram
  • Introduction to Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA)
    • Defining the what is, and what is not, RCA
    • Discussion on what constitutes a good CAPA
  • Why good Root Cause Analysis is key to good 8D / CAPA
  • Hands-on Exercises - Tools
Day 02(8:30 AM - 4:30 PM)
  • Refresher/review of Day One – Key Concepts
  • Hands-on Workshop – problem-solving tools (group exercise)
    • Review exercise
    • Define / apply which tools are best at each step
    • Derive the best solution(s) to the problem
  • Hands-on Workshop – 8-D Problem Solving tool (group exercise)
    • Work on exercise in teams
    • Gather data as needed
    • Determine which tools to apply when
    • Propose optimum solution based on information at hand
  • Common Mistakes and how to Design around them
    • Solutions don’t “stick”
    • Solution did not solve problem permanently
    • Data collection until “the end of time”
    • No buy-in from users or management
  • Applying 8D to various problems
    • Defect elimination
    • Customer satisfaction improvement
    • Internal defects / rework elimination
  • Questions
  • Summary
Seminar (Price/Register)
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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Speaker: Mary F McDonald, CEO, McDonald Consulting Group

Mary F. McDonald is a process quality specialist with over 25 years’ experience in large industries and small enterprises. Her experience allows her to design unique solutions to difficult problems, synthesizing tools from Lean, engineering, quality, environmental, and health/safety disciplines.

Ms. McDonald is currently the CEO/CTO of the McDonald Consulting Group (McDCG) in Austin, TX. McDCG is a recognized leader in providing process improvement consulting to a wide variety of customers in the healthcare, high technology, service, automotive, aerospace, semiconductor, and manufacturing disciplines. Her clients include Bayer, EDS, the FAA (Federal Aviation Administration), Huawei/HiSilicon, IBM, Motorola/Freescale, the University of Texas, Texas A&M University, and many others.

She holds a Master’s in Industrial Administration degree from Union College, Schenectady, NY, and a Bachelor’s in Environmental Engineering degree from Worcester Polytechnic Institute, Worcester, MA. An author of several academic pieces, she is the recipient of many industry awards. She also holds numerous professional society memberships and is well-known in these circles.


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