Standard Operating Procedure for Root Cause Analysis

1) Purpose

This SOP outlines the procedures for conducting root cause analysis (RCA) to systematically investigate and identify the underlying causes of deviations, incidents, non-conformances, or other quality issues within the pharmaceutical facility.

2) Scope

This SOP applies to all departments and personnel involved in investigating and resolving deviations, incidents, non-conformances, and quality issues within the pharmaceutical facility, including manufacturing, quality control, quality assurance, and engineering.

3) Responsibilities

The Quality Assurance Manager or designated personnel are responsible for overseeing the implementation of root cause analysis procedures. Department heads and supervisors are responsible for ensuring timely and thorough investigation and resolution of identified issues within their respective areas.

4) Procedure

4.1 Initiation of Root Cause Analysis

1. Identify and document the deviation, incident, non-conformance, or quality issue requiring root cause analysis.
2. Notify relevant personnel and initiate the RCA process promptly to prevent recurrence and minimize impact.

4.2 Investigation Team Formation

1. Form a multidisciplinary investigation team with expertise relevant to the issue under investigation, including subject matter experts, quality assurance, and operations personnel.
2. Assign a team leader responsible for coordinating the investigation activities and reporting.

4.3 RCA Methodologies

1. Select and apply appropriate RCA methodologies (e.g., 5 Whys, Fishbone diagram, Fault Tree Analysis) based on the complexity and nature of the issue.
2. Collect and analyze relevant data, facts, and evidence to identify potential root causes.

4.4 Root Cause Identification

1. Evaluate and prioritize identified root causes based on their likelihood and impact on the deviation or quality issue.
2. Verify root causes through objective evidence and consensus among investigation team members.

4.5 Corrective Actions

1. Develop and implement appropriate corrective actions to address identified root causes and prevent recurrence of the issue.
2. Assign responsibilities, establish timelines for implementation, and monitor progress of corrective actions.

4.6 Effectiveness Verification

1. Verify the effectiveness of implemented corrective actions through follow-up and monitoring.
2. Document verification activities and results to confirm closure of the RCA process.

5) Abbreviations, if any

SOP: Standard Operating Procedure
RCA: Root Cause Analysis

6) Documents, if any

RCA Investigation Report Template, Corrective and Preventive Action (CAPA) Form, RCA Methodology Guidelines

7) Reference, if any

Regulatory guidelines such as FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production, ICH Q9 Quality Risk Management, ISO 9001: Quality Management Systems – Requirements

8) SOP Version

Version 1.0