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A GUIDE TO
Root Cause Analysis
Root Cause Analysis (RCA) is a method of problem solving used for identifying the root causes of faults or problems. Root Cause Analysis on demand webinar.
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The 6 Common Mistakes of Root Cause Analysis
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Eventually, a problem will surface with every manufacturing process—suboptimal material, equipment failure, even nonconforming parts. Root cause analysis is a tool in the quality ecosystem that gives leadership the power to move beyond removing the nonconformity and actually improve designs and procedures, streamline processes, and anticipate and respond to emerging issues.
What is Root Cause Analysis?
Place data you’ve collected into a fishbone diagram, a “5 whys” process, or a Pareto chart—the three primary root cause analysis tools. Use their output to help you determine the primary causes of an incident. Each of these industry standard tools are outlined below.
What analysis tools can be used?
THREE ESSENTIAL RCA TOOLS
1. Fishbone Diagram
Karou Ishikawa created this tool in 1968 to help teams determine the potential root causes of a problem. The fishbone diagram gets its name from its layout. The problem is listed at one end and represents the “head” of the fish, and the six potential categories or areas of failure branch out like fishbones.
MEASUREMENT
MACHINES
METHODS
PEOPLE
MATERIALS
ENVIRONMENT
PROBLEM OR GOAL
MEASUREMENT
PEOPLE
ENVIRONMENT
MACHINES
METHODS
MATERIALS
PROBLEM OR GOAL
Karou Ishikawa created this tool in 1968 to help teams determine the potential root causes of a problem. The fishbone diagram gets its name from its layout. The problem is listed at one end and represents the “head” of the fish, and the six potential categories or areas of failure branch out like fishbones.
1. Fishbone Diagram
2. The Five Whys
Sakichi Toyoda, the founder of Toyota Industries, developed
the 5 Whys technique to move beyond the symptoms to the root cause of a problem. It can be used for troubleshooting, quality improvement, and solving problems of moderate complexity.
Manufacturer receives 1,500 coplaints worldwide of customers receiving empty viles of product solution.
Why?
Why are customers receiving Testosterone IVD Kits with 0ul of solution in vials?
Why is the solution leaving the vial or being destroyed in the vial?
Why?
Why is the vial gap loose?
Why?
Why is the torque machine out of calibration and has not been maintained for over 1-year?
Why?
Why is their no process or set schedule to maintain the torque machine for this product line?
Why?
The Pareto chart is named for Vilfredo Pareto, the father of the
“80/20” rule, which for quality professionals, postulates that 80% of the problems come from 20% of the issues. A Pareto chart is a quality tool that helps teams identify where to focus their efforts to achieve the greatest improvement.
3. Pareto Chart
Problem
Organizations use root cause analysis (RCA) to find the source of faults or problems in a manufacturing process. Although you can easily define a root cause, performing a root cause analysis is another matter. Mistakes are relatively common, but they don’t have to result in total do-overs. Learn more by downloading our free guide.
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Problem Areas
Cumulative Percentage
Watch ETQ’s Root Cause Analysis Fundamentals
On-Demand Webinar, where you'll learn:
How to perform a root cause analysis; Three essential root cause tools; How you can leverage QMS data to speed analysis and Overview of the Root Cause Analysis Toolkit
Interested in learning more about Root Cause Analysis?
Learn more
Watch ETQ’s Root Cause Analysis Fundamentals
On-Demand Webinar, where you'll learn:
How to perform a root cause analysis; Three essential root cause tools; How you can leverage QMS data to speed analysis and Overview of the Root Cause Analysis Toolkit
Interested in learning more about Root Cause Analysis?
Learn more
Learn how you can integrate the results of your RCA into your corrective action plans
Interested in learning more about Root Cause Analysis?
Download RCA Toolkit
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ETQ, part of Hexagon, is the leading provider of quality, EHS and compliance management SaaS software, trusted by the world’s strongest brands. More than 600 customers globally, spanning industries such as pharmaceuticals, electronics, heavy industry, food and beverage, and medical devices, benefit from ETQ to secure positive brand reputations, enable higher levels of customer loyalty and enhance profitability. ETQ Reliance offers built-in best practices and powerful flexibility to drive business excellence through quality. Only ETQ lets customers configure industry-proven quality processes to their unique needs and business vision. ETQ was founded in 1992 and has main offices located in the U.S. and Europe. To learn more about ETQ and its various product offerings, visit www.etq.com.
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