What is a Root Cause Classification?

Overview

Root Cause Analysis (RCA) is a structured approach to investigate the underlying causes of incidents or deviations and prevent recurrence. In pharmacy, RCA identifies system-level lapses that contribute to errors, promotes shared learning, and improves patient safety. Root Cause Classifications in SiCompounding provide a simple taxonomy (Category → Root Cause) to tag incidents, CAPA items, and QA findings for consistent analysis and reporting.

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Navigation Path

Settings → Quality Assurance → Root Cause Classification

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What is a Root Cause Classification?

A Root Cause Classification is a concise, reusable label used to categorize the underlying cause of an incident, deviation, or CAPA record. Classifications are structured as Category → Root Cause and are used across investigations to standardize reporting, trend analysis, and corrective action planning.

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Step-by-Step Instructions

Open FileMaker Pro

1. Click the FileMaker Pro icon to open FileMaker.
2. In FileMaker's left-side menubar select SiCompounding (near the top).
3. In the center icons, click Pharmacy to open the Dashboard.
4. From the blue sidebar, select Settings (bottom) → Quality Assurance → Root Cause Classification.

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Root Cause Classification Window (Overview)

The Root Cause Classification window presents a two-column layout used to manage classifications:

• Category — High-level grouping (example: Equipment failure)
• Root Cause — Specific cause within the category (examples: Lack of maintenance, Technical failure)

The Root Cause Classification window opens to a two-column input for each classification. Use the left column for Category and the right column for associated Root Causes.

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Fields Table

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Creating and Managing Classifications

1. Create a Category

   • Click the + button under Category.
   • The CAPA Classification popup opens.
   • Opens CAPA Classification popup — enter or change the Category name (and optional description), then click Save.

2. Edit or Delete a Category

   • Click the gear (⚙) icon next to a Category.
   • Choose Edit to modify the name or Delete to remove the record. Confirm deletion if prompted.

3. Add a Root Cause

   • Select the desired Category.
   • Click the + button under Root Cause.
   • The CAPA Classification popup opens. Enter the Root Cause text and click Save.
   • Opens CAPA Classification popup — enter or change the Root Cause text, then click Save.

4. Edit or Delete a Root Cause

   • Click the gear (⚙) icon next to a Root Cause.
   • Choose Edit to change the entry or Delete to remove it. Confirm deletion if prompted.

Best Practices

Note: Each + opens the same CAPA Classification popup used for creating or updating entries.

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Examples (Common Use Cases)

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Best Practices

• Use concise, standardized names for Categories and Root Causes to ensure consistent tagging across QA events.
• Model Categories to reflect your operational and reporting structure (e.g., Equipment, Process, Human Factors).
• Link Root Cause entries to CAPA workflows and incident records so investigations and corrective actions are traceable.
• Periodically review classifications and consolidate duplicates to keep the taxonomy useful.

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Pharmacy Settings (System Foundation)

Pharmacy Settings provide the foundational templates and defaults required for system operation. These settings must be completed before using other areas of SiCompounding.

Best Practice: Enter all available and required data for each section and subsection to ensure proper system behavior, compliance, and reporting across SiCompounding.

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This completes the guide for Root Cause Classification in SiCompounding.