Causal Analysis

Causal Analysis Module

This page contains information to assist our customers with utilizing the Causal Analysis module in RegScale. It describes what it is, why you would use it, the benefits, and provides instructions on getting started.

What is it?

A causal analysis is the process of using methods and tools to establish the relationship between cause and effect. The goal is to identify the root cause of any non-conformance or compliance deficiency so that it can be permanently eliminated through process improvement and corrective actions. Identifying a root cause is key as this is the problem that ultimately leads to the non-conformance. There are many proven techniques for performing causal analysis, to include:

• Event analysis
• Change analysis
• Barrier analysis
• Risk tree analysis
• Kepner-Tregoe Problem Solving and Decision Making
• Pareto analysis
• Fishbone Diagrams
• Failure Mode and Effects Analysis
• 5 Whys Analysis

Why would you use it?

Causal analysis is often performed to prevent recurrence of any non-conformance and to drive continuous improvement. When a major issue or non-conformance occurs, it is important to fully understand the root cause of the failure so that corrective actions have the highest probablity of being effective. Some of the reasons to perform causal analysis are shown below:

• Drive a deeper understanding of how the problem or non-conformance occurred
• Build a more effective Corrective Action Plan (CAP)
• Prevent recurrence of significant issues
• Drive continuous improvement processes (i.e. Lean/Six Sigma)
• Develop a timeline of the failure modes to document any system breakdowns
• Trending analysis for the cause of events to identify broader systemic or cultural issues

What are the benefits?

A strong causal analysis program results in multiple benefits for an organization; to include:

• Improve quality by eliminating the causes of non-conformances
• Lower costs by reducing the number of defects
• Improve compliance by eliminating the cause of issues and prevent recurrence
• Reduce risk by avoiding future problems
• Improve transparency through automated dashboards

How do I use it?

The causal analysis module in RegScale Community Edition (CE) provides a number of key features that are useful in managing a robust program, to include:

• Linking causal analysis efforts to assessments/issues
• Tracking progress against completing causal analysis (due dates, # overdue, etc.)
• Documenting and assigning corrective actions
• Real-time tracking and dashboards
• Single pane of glass assignment tracking via our work bench
• Automated workflows for review and approval
• Interactive timeline builder
• Social collaboration via our News Feed (LinkedIn for Compliance) and real-time commenting system
• Secure evidence management with our file upload and encryption system
• Audit history including every view, update, print, email, etc.
• Calendar view to see causal analysis efforts due within any given period

For our Enterprise Edition (EE) customers, you get all the great features above, plus we add:

• Ability to create custom fields to extend the schema and build out customer specific data entry forms
• Integration with Microsoft Teams and Slack for real-time collaboration
• Ability to host a multi-tenant version to segregate data by site, customer, organization, etc. to run many different causal analysis programs with complete data isolation from a single installation
• Real-time interactive dashboard with Microsoft PowerBI AddOn
• Facility specific views of causal analysis due dates with Geographic Information System (GIS) overlays