Root Cause Analysis: Identification & Evaluation

Root Cause Analysis Overview

This section provides a structured summary of all identified root causes within the investigation, including key details such as identification date, classification, and analysis methodology. The Root Cause Overview includes the following columns:

• Root Cause Description and Methodology: Clearly outlines the identified root causes, along with the analytical techniques used (e.g., Fishbone Diagram, Five Whys Analysis).

• Date of Identification: Displays when the root cause was officially documented.

• Type of Root Cause: Specifies whether the issue is related to a process, procedural, equipment, or other systemic failure affecting compliance and operations.

• Category of Root Cause: Categorizes the issue, such as Cleaning Validation, Documentation, or Training Deficiency, helping to determine systemic weaknesses.

• View Details: Click the eye icon to access an in-depth view of each root cause.

To document an additional root cause, click the plus icon in the top-right corner. You can modify the date, type, and category directly from the table.

Root Cause Information

The Root Cause Registration section allows you to define and document key details about the identified cause of an issue. This includes type, category, classification, frequency, and method of analysis, ensuring a comprehensive evaluation of the root cause. Fields marked with an asterisk (*) are mandatory for record creation and proper functionality.

Root Cause Audit Trail

The audit trail maintains a chronological, uneditable log of all recorded root causes, ensuring data integrity, compliance, and traceability. Click the audit trail icon to view event details, including performed actions, timestamps, and responsible users.

Pressing the print icon allows users to print or download the audit trail report.

When printed, the report will include a stamp with a unique control number, the name of the user who initiated the print, and a timestamp detailing the date and time it was generated. This information is located in the document footer, as shown in the example below. The design complies with cGMPs, ALCOA, ALCOA+, and other data integrity and security standards for forms and documents.