Root Cause Analysis - How It Informs CAPA

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. Root Cause Analysis: How it Informs CAPA

2. 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

3. 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

4. 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.

5. What are Root Causes? S pecific 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

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

7. 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?

8. How many CAPAs did you process in 2020?

9. 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?

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

11. Output from RCA Corrective Action Preventive Action RCA Outputs

12. 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.

13. How to Conduct an RCA Define the problem. Ensure you identify the problem and align with a customer need Collect data relating to the problem Identify what is causing the problem Prioritize the causes Identify solutions to the underlying problem and implement the change Monitor and sustain

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

15. 5 Whys

16. 5 Whys Example

17. 5 Whys Example

18. Fishbone

19. Fishbone Analysis

20. Fishbone Analysis - Identify Problem Statement

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

22. RCA - CAPA Safety Chain Case Management RCA and CAPA Management

23. RCA - SafetyChain Using Cases RCA-CAPA Visibility

24. RCA - SafetyChain Using Cases RCA-CAPA Summary Display

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

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

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

28. BEYOND COMPLIANCE