For years, we've performed root cause analysis with whiteboards, Post-Its & spreadsheets using The 5 Whys, Ishikawa diagrams, FMEA, and DMAIC methodologies. Now, newer technologies have made the RCA discovery process faster and more precise, and support a direct link to CAPAs.

1. Beyond Compliance
Webinar & Podcast Series for Food, Beverage, & CPG Manufacturers
Root Cause Analysis:
How it Informs CAPA

2. The Sponsor
✔Improve Yield
✔Maximize Productivity
✔Ensure Compliance
Plant Management Platform
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3. Before we get started
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Helpful tips
✔Informal, conversational approach
✔Ask Questions (Q&A at end)
✔Only panelists are displayed/heard
✔Recording & slides links shared on request
✔Audio issues? Use call-in number

4. About the Presenters
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Kevin Lee
Sr. Solutions Architect
Kevin brings 25+ years of manufacturing,
distribution and supply chain experiences. For
over 10 years, Kevin has worked in the Quality
Risk and Compliance arenas with companies
regulated by the FDA. Kevin specializes in
manufacturing & supplier quality management
and is seasoned in ERP-Plant Management
integrations with ERP and WMS
implementations for 10+ years.
Aaron Bolshaw
VP of Marketing

5. BEYOND COMPLIANCE
What is Root Cause Analysis (RCA)?
● A method to help identify what, how, and why an event
occurred so that steps can be taken to prevent future
occurrences.
● Involves data collecting, root cause identification, and
recommendation generation and implementation.
● RCA is an application of techniques that enables you to look
beneath the surface, explore the causal pathways from the
problem leading to its true root cause/s.

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What are Root Causes?
Specific underlying causes that can be
reasonably identified, are within
management's control to remedy, and that
generate effective recommendations to
prevent recurrences.
Above the surface we see symptoms, below
the surface we find root causes

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What is CAPA
● Corrective Action
■ Action designed to correct the problem
● Preventive Action
■ Action designed to prevent the problem’s
reoccurrence.

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Root Cause Analysis
Systematically discovering the reason for a problem
CA- Corrective Action
taken to ensure that the same problem does take place again (does not recur)
PA- Preventive Action
(Actions to prevent the problem from taking place
What is the Connection Between RCA and CAPA?

9. How many CAPAs did you process in 2020?

10. BEYOND COMPLIANCE
• To ensure quality improvements of processes and functions
• To maintain the quality of products and services
• To satisfy the needs and expectations of the customers all the time
Why Are RCAs and CAPAs Required?

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Input Problems
• Non-Conformances
• Complaints
• Deviations
• Incidents
• Recalls/Returns
RCA Inputs

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Output from RCA
• Corrective Action
• Preventive Action
RCA Outputs

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When to Conduct a RCA?
Root Cause Analysis can identify breakdowns in
your processes or systems that contributed to
non-conformance and determine how to prevent it
from happening again.
An RCA is performed to identify what happened,
why it happened, and then determine what
improvements or changes are required.

14. BEYOND COMPLIANCE
How to Conduct an RCA
1. Define the problem. Ensure you identify the
problem and align with a customer need
2. Collect data relating to the problem
3. Identify what is causing the problem
4. Prioritize the causes
5. Identify solutions to the underlying problem
and implement the change
6. Monitor and sustain

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● Pareto Chart
● The 5 Whys
● Fishbone Diagram
● Failure Mode and Effects
Analysis (FMEA)
Pareto Chart Example
Common RCA Investigation Tools

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5 Whys

17. 5 Whys Example

18. 5 Whys Example

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Fishbone

20. Fishbone Analysis

21. Fishbone Analysis - Identify Problem Statement

22. How long does it take you to get to a root cause on average?

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RCA - CAPA Safety Chain Case Management
RCA and CAPA Management

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RCA - SafetyChain Using Cases
RCA-CAPA Visibility

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RCA - SafetyChain Using Cases
RCA-CAPA Summary Display

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RCA - SafetyChain Using Cases
RCA-CAPA Summary Display - Investigation

27. Typically, how many departments are involved in your
RCA/CAPA resolutions?

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Using Technology (Software) Provides Better Accuracy & Speed
Quicker Training
Predicting &
Preventing Issues
Trending the Data

29. Q & A
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30. Resources
White Papers & Surveys
Webinars & Videos
Product & Partner Info
Solution Consultation
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